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Clinical Evaluation of MDT-2111 in Subjects With Symptomatic Severe Aortic Stenosis

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ClinicalTrials.gov Identifier: NCT01437098
Recruitment Status : Active, not recruiting
First Posted : September 20, 2011
Results First Posted : June 6, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Aortic Valve Stenosis
Intervention Device: MDT-2111 CoreValve for TAVI
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MDT-2111 TAVI
Hide Arm/Group Description Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
Period Title: Overall Study
Started 55
30 Days 51
6 Months 47
12 Months 45
24 Months 42
36 Months 36
Completed 42
Not Completed 13
Arm/Group Title MDT-2111 TAVI
Hide Arm/Group Description Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
Overall Number of Baseline Participants 55
Hide Baseline Analysis Population Description
As Treated Subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants
82.5  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants
Female
38
  69.1%
Male
17
  30.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 55 participants
55
NYHA Class   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 55 participants
NYHA Class II 0
NYHA Class III 49
NYHA Class IV 6
[1]
Measure Description: New York Heart Association Classification (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Class II Subjects with cardiac disease resulting in slight limitation of physical activity. Class III Subjects with cardiac disease resulting in marked limitation of physical activity. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.
STS Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 55 participants
8.0  (4.2)
[1]
Measure Description: The Society of Thoracic Surgeons (STS) risk model predicts the risk of operative mortality and morbidity after adult cardiac surgery on the basis of patient demographic and clinical variables. After information has been entered on a given case, the online STS risk calculator provides a risk percentage for each of the outcomes. The risk percentage estimates the chance of a specific outcome for a patient with the indicated risk factors. A higher score indicates a higher risk. A lower score indicates a lower risk.
Logistic EuroScore   [1] 
Mean (Standard Deviation)
Unit of measure:  Percent
Number Analyzed 55 participants
21.5  (9.9)
[1]
Measure Description: The European System for Cardiac Operative Risk Evaluation (EuroSCORE) is a method of calculating predicted operative mortality for patients undergoing cardiac surgery. If a risk factor is present, a weight/number is assigned. The weights are added to give an approximate percent of predicted mortality. A higher score indicates a higher risk. A lower score indicates a lower risk..
Aortic Valve Area (AVA)  
Mean (Standard Deviation)
Unit of measure:  Cm²
Number Analyzed 55 participants
0.6  (0.1)
1.Primary Outcome
Title Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).
Hide Description The primary endpoint was defined as the proportion of implanted subjects with improvement of at least 1 NYHA class from baseline to 6 months and EOA greater than 1.2 cm² at 6 months.
Time Frame baseline and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects implanted with the MDT-2111 device.
Arm/Group Title All Implanted Subjects Iliofemoral Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47 36
Measure Type: Number
Unit of Measure: percentage of participants
93.6 91.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Iliofemoral Implanted Subjects
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Exact binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion of IF Implanted Subjects
Estimated Value 91.7
Confidence Interval (2-Sided) 95%
77.5 to 98.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title NYHA Classification Over Time
Hide Description

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
NYHA denominators included deaths (n=2). Taken deaths out, you have n=51 at 30 days.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
NYHA I 58.5
NYHA II 30.2
NYHA III 5.7
NYHA IV 1.9
Died prior to visit 3.8
3.Secondary Outcome
Title NYHA Classification Over Time
Hide Description

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
NYHA I 59.6
NYHA II 30.8
NYHA III 0.0
NYHA IV 0.0
Died prior to visit 9.6
4.Secondary Outcome
Title NYHA Classification Over Time
Hide Description

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 12 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
NYHA I 60.4
NYHA II 24.5
NYHA III 0.0
NYHA IV 0.0
Died prior to visit 15.1
5.Secondary Outcome
Title NYHA Classification Over Time
Hide Description

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
NYHA I 59.6
NYHA II 21.2
NYHA III 0.0
NYHA IV 0.0
Died prior to visit 19.2
6.Secondary Outcome
Title NYHA Classification Over Time
Hide Description

NEW YORK HEART ASSOCIATION CLASSIFICATION (NYHA) Class I Subject with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

Class II Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

Class III Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, palpitation, dyspnea, or anginal pain.

Class IV Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency or of the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.

Time Frame 36 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: percentage of participants
NYHA I 57.7
NYHA II 9.6
NYHA III 0
NYHA IV 0
Died prior to visit 32.7
7.Secondary Outcome
Title Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Hide Description

MACCE is defined as a composite of:

  • all-cause death
  • myocardial infarction (MI)
  • all stroke, and
  • reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame 0 day to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Kaplan-Meier Method was used to calculate the number.
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 30 days
89.1
8.Secondary Outcome
Title Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Hide Description

MACCE is defined as a composite of:

  • all-cause death
  • myocardial infarction (MI)
  • all stroke, and
  • reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame 0 day to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Kaplan-Meier Method was used to calculate the number.
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 183 days
81.6
9.Secondary Outcome
Title Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Hide Description

MACCE is defined as a composite of:

  • all-cause death
  • myocardial infarction (MI)
  • all stroke, and
  • reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame 0 day to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Kaplan-Meier Method was used to calculate the number.
Arm/Group Title As Treated (AT) Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 365 days
76.1
10.Secondary Outcome
Title Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Hide Description

MACCE is defined as a composite of:

  • all-cause death
  • myocardial infarction (MI)
  • all stroke, and
  • reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame 0 day to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Kaplan-Meier Method was used to calculate the number.
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event at 730 days
68.4
11.Secondary Outcome
Title Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)
Hide Description

MACCE is defined as a composite of:

  • all-cause death
  • myocardial infarction (MI)
  • all stroke, and
  • reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve)
Time Frame 0 day to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Kaplan-Meier Method was used to calculate the number.
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event at 1095 days
57.3
12.Secondary Outcome
Title Device Success as Defined in the Description.
Hide Description
  • successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system
  • correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)
  • Intended performance of the prosthetic valve (aortic valve area >1.2 cm² (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/sec, without moderate or severe prosthetic valve AR)
  • Only one valve implanted in the proper anatomical location
Time Frame after procedure or discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The AT cohort that went through an index procedure were analyzed for Device Success. Also, all components that went into the success measures had to be non-missing. Therefore n=53.
Arm/Group Title As Treated Population With Index Procedure
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
Overall Number of Participants Analyzed 53
Measure Type: Number
Unit of Measure: percentage of participants
90.6
13.Secondary Outcome
Title Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.
Hide Description [Not Specified]
Time Frame after procedure or discharge
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population With Index Procedure
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
81.5
14.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: mmHg
9.5  (3.4)
15.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: mmHg
8.9  (2.3)
16.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: mmHg
9.4  (3.0)
17.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had mean gradients available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: mmHg
8.4  (2.6)
18.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient
Hide Description [Not Specified]
Time Frame 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 33
Mean (Standard Deviation)
Unit of Measure: mmHg
8.9  (3.0)
19.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: cm²
1.8  (0.4)
20.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: cm²
1.8  (0.4)
21.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: cm²
1.7  (0.4)
22.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had EOA measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 38
Mean (Standard Deviation)
Unit of Measure: cm²
1.8  (0.5)
23.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)
Hide Description [Not Specified]
Time Frame 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: cm²
1.8  (0.4)
24.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 51
Mean (Standard Deviation)
Unit of Measure: percent
63.9  (6.6)
25.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47
Mean (Standard Deviation)
Unit of Measure: percent
63.8  (7.7)
26.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: percent
62.9  (7.0)
27.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 42
Mean (Standard Deviation)
Unit of Measure: percent
64.3  (6.3)
28.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)
Hide Description [Not Specified]
Time Frame 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: percent
61.1  (7.8)
29.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Hide Description [Not Specified]
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 50
Measure Type: Number
Unit of Measure: percentage of participants
None 8.0
Trace 48.0
Mild 38.0
Moderate 6.0
Severe 0.0
30.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of participants
None 31.9
Trace 31.9
Mild 31.9
Moderate 4.3
Severe 0.0
31.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 45
Measure Type: Number
Unit of Measure: percentage of participants
None 24.4
Trace 26.7
Mild 44.4
Moderate 4.4
Severe 0.0
32.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Hide Description [Not Specified]
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Total AR available at 24 months were analyzed. Not everyone followed to 24 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: percentage of participants
None 17.1
Trace 41.5
Mild 36.6
Moderate 4.9
Severe 0.0
33.Secondary Outcome
Title Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)
Hide Description [Not Specified]
Time Frame 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had LVEF measurement available at 36 months were analyzed. Not everyone followed to 36 months had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 35
Measure Type: Number
Unit of Measure: percentage of participants
None 25.7
Trace 31.4
Mild 37.1
Moderate 5.7
Severe 0.0
34.Secondary Outcome
Title Repeat Hospitalization
Hide Description [Not Specified]
Time Frame 0 day to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 30 days
94.3
35.Secondary Outcome
Title Repeat Hospitalization
Hide Description [Not Specified]
Time Frame 0 day to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 183 days
61.0
36.Secondary Outcome
Title Repeat Hospitalization
Hide Description [Not Specified]
Time Frame 0 day to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 365 days
50.9
37.Secondary Outcome
Title Repeat Hospitalization
Hide Description [Not Specified]
Time Frame 0 day to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 730 days
37.4
38.Secondary Outcome
Title Repeat Hospitalization
Hide Description [Not Specified]
Time Frame 0 day to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 1095 days
35.9
39.Secondary Outcome
Title Valve-related Deaths
Hide Description [Not Specified]
Time Frame 0 day to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 30 days
98.2
40.Secondary Outcome
Title Valve-related Deaths
Hide Description [Not Specified]
Time Frame 0 day to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 183 days
98.2
41.Secondary Outcome
Title Valve-Related Deaths
Hide Description [Not Specified]
Time Frame 0 day to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 365 days
98.2
42.Secondary Outcome
Title Valve-related Deaths
Hide Description [Not Specified]
Time Frame 0 day to 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 730 days
98.2
43.Secondary Outcome
Title Valve-related Deaths
Hide Description [Not Specified]
Time Frame 0 day to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title As Treated Population
Hide Arm/Group Description:
The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
Overall Number of Participants Analyzed 55
Measure Type: Number
Unit of Measure: prob of freedom from event @ 1095 days
94.5
44.Secondary Outcome
Title Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
Hide Description The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.
Time Frame Baseline to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The implanted cohorts that had non-missing data at this time point were analyzed. Implanted subjects that had Q of L available at this visit were analyzed. Not everyone followed to this visit had this measurement. This is true of all other echo data results, and explains if the number is different from the Number of Participants Analyzed.
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 50
Median (Inter-Quartile Range)
Unit of Measure: Points
5.2
(-8.1 to 18.4)
45.Secondary Outcome
Title Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
Hide Description The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.
Time Frame Baseline to 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 47
Median (Inter-Quartile Range)
Unit of Measure: Points
11.2
(1.4 to 23.8)
46.Secondary Outcome
Title Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
Hide Description The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.
Time Frame Baseline to 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 45
Median (Inter-Quartile Range)
Unit of Measure: Points
10.8
(-5.6 to 24.2)
47.Secondary Outcome
Title Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
Hide Description The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.
Time Frame Baseline to 24 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 41
Median (Inter-Quartile Range)
Unit of Measure: Points
9.3
(-5.3 to 20.1)
48.Secondary Outcome
Title Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)
Hide Description The SF-36 assessment was used to evaluate subject Quality of life (QoL) by assessing change in physical function and general health status. The SF-36 v2TM Scoring Program2,3 was used to convert raw scores ranging from 0 to 100 into norm-based scores, allowing direct comparison to the reference values for the Japanese population. A norm-based score of less than 50 was interpreted as below average when compared to the Japanese population whereas norm-based scores greater than 50 were interpreted as above average.
Time Frame Baseline to 36 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Implanted Subjects
Hide Arm/Group Description:
The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
Overall Number of Participants Analyzed 34
Median (Inter-Quartile Range)
Unit of Measure: Points
4.8
(-6.2 to 16.0)
Time Frame Serious Adverse Events (SAEs) must be reported to the study sponsor by the investigator or study staff within 24 hours after the investigator first learns of event.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iliofemoral (As Treated Subjects) Subclavian (As Treated Subjects) Direct Aortic (As Treated Subjects) All Subjects (As Treated Subjects)
Hide Arm/Group Description The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients. The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries. For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches. This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
All-Cause Mortality
Iliofemoral (As Treated Subjects) Subclavian (As Treated Subjects) Direct Aortic (As Treated Subjects) All Subjects (As Treated Subjects)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Iliofemoral (As Treated Subjects) Subclavian (As Treated Subjects) Direct Aortic (As Treated Subjects) All Subjects (As Treated Subjects)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/44 (90.91%)      4/5 (80.00%)      5/6 (83.33%)      49/55 (89.09%)    
Blood and lymphatic system disorders         
Anaemias Nec * 1  2/44 (4.55%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  3
Cardiac disorders         
Aortic Valvular Disorders * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Cardiac Conduction Disorders * 1  11/44 (25.00%)  11 2/5 (40.00%)  2 0/6 (0.00%)  0 13/55 (23.64%)  13
Cardiac Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Coronary Artery Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  2
Heart Failures Nec * 1  6/44 (13.64%)  15 1/5 (20.00%)  1 3/6 (50.00%)  6 10/55 (18.18%)  22
Ischaemic Coronary Artery Disorders * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Myocardial Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Pericardial Disorders Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Supraventricular Arrhythmias * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Ventricular Arrhythmias And Cardiac Arrest * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Eye disorders         
Cataract Conditions * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Gastrointestinal disorders         
Gastrointestinal Ulcers And Perforation, Site Unspecified * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Non-Site Specific Gastrointestinal Haemorrhages * 1  4/44 (9.09%)  4 0/5 (0.00%)  0 1/6 (16.67%)  1 5/55 (9.09%)  5
General disorders         
Asthenic Conditions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Death And Sudden Death * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Device Issues Nec * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Febrile Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
General Signs And Symptoms Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Pain And Discomfort Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Hepatobiliary disorders         
Cholecystitis And Cholelithiasis * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Hepatic Enzymes And Function Abnormalities * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Hepatic Failure And Associated Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Obstructive Bile Duct Disorders (Excl Neoplasms) * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Infections and infestations         
Abdominal And Gastrointestinal Infections * 1  1/44 (2.27%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  2
Bacterial Infections Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 1/6 (16.67%)  1 3/55 (5.45%)  3
Infections Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Lower Respiratory Tract And Lung Infections * 1  5/44 (11.36%)  7 0/5 (0.00%)  0 2/6 (33.33%)  5 7/55 (12.73%)  12
Sepsis, Bacteraemia, Viraemia And Fungaemia Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Stretococcal Infections * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Injury, poisoning and procedural complications         
Cerebral Injuries Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Lower Limb Fractures And Dislocations * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Non-Site Specific Injuries Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Non-Site Specific Procedural Complications * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Pelvic Fractures And Dislocations * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Spinal Fractures And Dislocations * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Investigations         
Physical Examination Procedures * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Metabolism and nutrition disorders         
Diabetes Mellitus (Incl Subtypes) * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  2
General Nutritional Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders         
Muscle Weakness Conditions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal And Connective Tissue Pain And Discomfort * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Osteoarthropathies * 1  2/44 (4.55%)  3 1/5 (20.00%)  1 0/6 (0.00%)  0 3/55 (5.45%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast And Nipple Neoplasms Malignant * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Hepatic Neoplasms Malignant * 1  2/44 (4.55%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  3
Hepatobiliary Neoplasms Malignancy Unspecified * 1  1/44 (2.27%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  2
Lymphomas Unspecified Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders         
Central Nervous System Haemorrhages And Cerebrovascular Accidents * 1  6/44 (13.64%)  6 0/5 (0.00%)  0 2/6 (33.33%)  2 8/55 (14.55%)  8
Central Nervous System Vascular Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Psychiatric disorders         
Anxiety Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Renal and urinary disorders         
Renal Failure And Impairment * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Renal Vascular And Ischaemic Conditions * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Reproductive system and breast disorders         
Pelvic Prolapse Conditions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders         
Breathing Abnormalities * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Lower Respiratory Tract Inflammatory And Immunologic Conditions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Mediastinal Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Nasal Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Parenchymal Lung Disorders Nec * 1  1/44 (2.27%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  2
Pneumothorax And Pleural Effusions Nec * 1  1/44 (2.27%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  2
Pulmonary Oedemas * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Respiratory Failures (Excl Neonatal) * 1  2/44 (4.55%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  3
Upper Respiratory Tract Signs And Symptoms * 1  0/44 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/55 (1.82%)  1
Skin and subcutaneous tissue disorders         
Dermatitis Ascribed To Specific Agent * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Vascular disorders         
Aortic Aneurysms And Dissections * 1  0/44 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/55 (1.82%)  1
Circulatory Collapse And Shock * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Peripheral Embolism And Thrombosis * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Vascular Hypotensive Disorders * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iliofemoral (As Treated Subjects) Subclavian (As Treated Subjects) Direct Aortic (As Treated Subjects) All Subjects (As Treated Subjects)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/44 (100.00%)      5/5 (100.00%)      6/6 (100.00%)      55/55 (100.00%)    
Blood and lymphatic system disorders         
Anaemias Nec * 1  13/44 (29.55%)  13 1/5 (20.00%)  2 2/6 (33.33%)  2 16/55 (29.09%)  17
Coagulopathies * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Thrombocytopenias * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Cardiac disorders         
Cardiac Conduction Disorders * 1  27/44 (61.36%)  39 4/5 (80.00%)  4 2/6 (33.33%)  3 33/55 (60.00%)  46
Cardiac Signs And Symptoms Nec * 1  3/44 (6.82%)  5 1/5 (20.00%)  1 0/6 (0.00%)  0 4/55 (7.27%)  6
Heart Failures Nec * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 1/6 (16.67%)  1 3/55 (5.45%)  3
Ischaemic Coronary Artery Disorders * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Mitral Valvular Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Pericardial Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Rate And Rhythm Disorders Nec * 1  4/44 (9.09%)  4 0/5 (0.00%)  0 1/6 (16.67%)  1 5/55 (9.09%)  5
Supraventricular Arrhythmias * 1  9/44 (20.45%)  11 0/5 (0.00%)  0 2/6 (33.33%)  3 11/55 (20.00%)  14
Ventricular Arrhythmias And Cardiac Arrest * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Ear and labyrinth disorders         
Ear Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Inner Ear Signs And Symptoms * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Endocrine disorders         
Adrenal Cortical Hypofunctions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Thyroid Hypofunction Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Eye disorders         
Cataract Conditions * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Gastrointestinal disorders         
Diarrhoea (Excl Infective) * 1  2/44 (4.55%)  2 2/5 (40.00%)  2 2/6 (33.33%)  3 6/55 (10.91%)  7
Gastrointestinal Atonic And Hypomotility Disorders Nec * 1  7/44 (15.91%)  7 1/5 (20.00%)  2 2/6 (33.33%)  2 10/55 (18.18%)  11
Gastrointestinal Inflammatory Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Gastrointestinal Signs And Symptoms Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Nausea And Vomiting Symptoms * 1  8/44 (18.18%)  8 1/5 (20.00%)  1 1/6 (16.67%)  2 10/55 (18.18%)  11
Non-Site Specific Gastrointestinal Haemorrhages * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Oral Soft Tissue Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Tongue Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Tongue Signs And Symptoms * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
General disorders         
Administration Site Reactions Nec * 1  4/44 (9.09%)  4 2/5 (40.00%)  2 1/6 (16.67%)  2 7/55 (12.73%)  8
Asthenic Conditions * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Complications Associated With Device Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Febrile Disorders * 1  11/44 (25.00%)  11 2/5 (40.00%)  2 2/6 (33.33%)  2 15/55 (27.27%)  15
Feelings And Sensations Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Implant And Catheter Site Reactions * 1  3/44 (6.82%)  3 1/5 (20.00%)  1 0/6 (0.00%)  0 4/55 (7.27%)  4
Inflammations * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 1/6 (16.67%)  1 4/55 (7.27%)  4
Injection Site Reactions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  2
Oedema Nec * 1  8/44 (18.18%)  9 0/5 (0.00%)  0 1/6 (16.67%)  1 9/55 (16.36%)  10
Pain And Discomfort Nec * 1  3/44 (6.82%)  5 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  5
Hepatobiliary disorders         
Hepatic Enzymes And Function Abnormalities * 1  2/44 (4.55%)  2 1/5 (20.00%)  2 0/6 (0.00%)  0 3/55 (5.45%)  4
Infections and infestations         
Bacterial Infections Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Infections Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Staphylococcal Infections * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Tinea Infections * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Upper Respiratory Tract Infections * 1  5/44 (11.36%)  9 1/5 (20.00%)  2 0/6 (0.00%)  0 6/55 (10.91%)  11
Urinary Tract Infections * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 2/6 (33.33%)  2 4/55 (7.27%)  4
Injury, poisoning and procedural complications         
Fractures And Dislocations Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Gastrointestinal And Hepatobiliary Procedural Complications * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Non-Site Specific Injuries Nec * 1  10/44 (22.73%)  10 1/5 (20.00%)  1 5/6 (83.33%)  6 16/55 (29.09%)  17
Non-Site Specific Procedural Complications * 1  12/44 (27.27%)  16 0/5 (0.00%)  0 4/6 (66.67%)  4 16/55 (29.09%)  20
Skin Injuries Nec * 1  4/44 (9.09%)  4 0/5 (0.00%)  0 0/6 (0.00%)  0 4/55 (7.27%)  4
Spinal Fractures And Dislocations * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Investigations         
Blood Counts Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Coagulation And Bleeding Analyses * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Faecal Analyses Nec * 1  0/44 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/55 (1.82%)  1
Heart Rate And Pulse Investigations * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Lipoprotein And Lipid Tests Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  2
Liver Function Analyses * 1  12/44 (27.27%)  16 1/5 (20.00%)  1 2/6 (33.33%)  2 15/55 (27.27%)  19
Metabolism Tests Nec * 1  5/44 (11.36%)  6 0/5 (0.00%)  0 3/6 (50.00%)  4 8/55 (14.55%)  10
Mineral And Electrolyte Analyses * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  2
Physical Examination Procedures * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Platelet Analyses * 1  10/44 (22.73%)  10 1/5 (20.00%)  1 1/6 (16.67%)  1 12/55 (21.82%)  12
Protein Analyses Nec * 1  29/44 (65.91%)  31 3/5 (60.00%)  3 2/6 (33.33%)  2 34/55 (61.82%)  36
Red Blood Cell Analyses * 1  6/44 (13.64%)  6 0/5 (0.00%)  0 0/6 (0.00%)  0 6/55 (10.91%)  6
Renal Function Analyses * 1  3/44 (6.82%)  3 1/5 (20.00%)  1 1/6 (16.67%)  1 5/55 (9.09%)  5
Skeletal And Cardiac Muscle Analyses * 1  12/44 (27.27%)  15 3/5 (60.00%)  3 6/6 (100.00%)  7 21/55 (38.18%)  25
Tissue Enzyme Analyses Nec * 1  7/44 (15.91%)  10 0/5 (0.00%)  0 3/6 (50.00%)  3 10/55 (18.18%)  13
Triglyceride Analyses * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Urinary Tract Function Analyses Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Vascular Tests Nec (Incl Blood Pressure) * 1  14/44 (31.82%)  19 2/5 (40.00%)  2 3/6 (50.00%)  4 19/55 (34.55%)  25
White Blood Cell Analyses * 1  12/44 (27.27%)  12 3/5 (60.00%)  3 0/6 (0.00%)  0 15/55 (27.27%)  15
Metabolism and nutrition disorders         
Appetite Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  2
Diabetes Mellitus (Incl Subtypes) * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 2/6 (33.33%)  2 2/55 (3.64%)  2
Disorders Of Purine Metabolism * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
General Nutritional Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Hyperglycaemic Conditions Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Potassium Imbalance * 1  5/44 (11.36%)  5 0/5 (0.00%)  0 1/6 (16.67%)  1 6/55 (10.91%)  6
Protein Metabolism Disorders Nec * 1  5/44 (11.36%)  5 0/5 (0.00%)  0 2/6 (33.33%)  2 7/55 (12.73%)  7
Total Fluid Volume Decreased * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Musculoskeletal and connective tissue disorders         
Connective Tissue Disorders (Excl Le) * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Joint Related Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal And Connective Tissue Pain And Discomfort * 1  6/44 (13.64%)  6 0/5 (0.00%)  0 1/6 (16.67%)  1 7/55 (12.73%)  7
Musculoskeletal And Connective Tissue Signs And Symptoms Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Osteoarthropathies * 1  0/44 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/55 (1.82%)  1
Soft Tissue Disorders Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Tendon Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Nervous system disorders         
Central Nervous System Haemorrhages And Cerebrovascular Accidents * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Cortical Dysfunction Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Headaches Nec * 1  1/44 (2.27%)  2 0/5 (0.00%)  0 1/6 (16.67%)  1 2/55 (3.64%)  3
Neurological Signs And Symptoms Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Paralysis And Paresis (Excl Cranial Nerve) * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Sensory Abnormalities Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Vagus Nerve Disorders * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Psychiatric disorders         
Anxiety Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Anxiety Symptoms * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Depressive Disorders * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Disturbances In Initiating And Maintaining Sleep * 1  3/44 (6.82%)  3 1/5 (20.00%)  1 0/6 (0.00%)  0 4/55 (7.27%)  4
Increased Physical Activity Levels * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Renal and urinary disorders         
Renal Failure And Impairment * 1  5/44 (11.36%)  5 1/5 (20.00%)  1 2/6 (33.33%)  2 8/55 (14.55%)  8
Urinary Abnormalities * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Reproductive system and breast disorders         
Breast Disorders Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Breast Signs And Symptoms * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Vulvovaginal Disorders Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Respiratory, thoracic and mediastinal disorders         
Breathing Abnormalities * 1  3/44 (6.82%)  4 1/5 (20.00%)  1 0/6 (0.00%)  0 4/55 (7.27%)  5
Coughing And Associated Symptoms * 1  1/44 (2.27%)  1 1/5 (20.00%)  1 0/6 (0.00%)  0 2/55 (3.64%)  2
Nasal Disorders Nec * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  2 1/55 (1.82%)  2
Pneumothorax And Pleural Effusions Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 2/6 (33.33%)  2 4/55 (7.27%)  4
Pulmonary Oedemas * 1  0/44 (0.00%)  0 1/5 (20.00%)  1 2/6 (33.33%)  2 3/55 (5.45%)  3
Respiratory Failures (Excl Neonatal) * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Upper Respiratory Tract Signs And Symptoms * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Skin and subcutaneous tissue disorders         
Dermal And Epidermal Conditions Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Dermatitis And Eczema * 1  3/44 (6.82%)  3 1/5 (20.00%)  1 1/6 (16.67%)  1 5/55 (9.09%)  5
Dermatitis Ascribed To Specific Agent * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Erythemas * 1  1/44 (2.27%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  2
Exfoliative Conditions * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Hyperkeratoses * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Ichthyoses * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Pruritus Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Purpura And Related Conditions * 1  0/44 (0.00%)  0 0/5 (0.00%)  0 1/6 (16.67%)  1 1/55 (1.82%)  1
Skin And Subcutaneous Tissue Ulcerations * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 3/55 (5.45%)  3
Skin Haemorrhages * 1  2/44 (4.55%)  3 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  3
Skin Injuries And Mechanical Dermatoses * 1  2/44 (4.55%)  4 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  4
Vascular disorders         
Aortic Aneurysms And Dissections * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Blood Pressure Disorders Nec * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 1/6 (16.67%)  1 3/55 (5.45%)  3
Haemorrhages Nec * 1  0/44 (0.00%)  0 1/5 (20.00%)  1 0/6 (0.00%)  0 1/55 (1.82%)  1
Non-Site Specific Necrosis And Vascular Insufficiency Nec * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Peripheral Aneurysms And Dissections * 1  2/44 (4.55%)  2 0/5 (0.00%)  0 0/6 (0.00%)  0 2/55 (3.64%)  2
Peripheral Vasoconstriction, Necrosis And Vascular Insufficiency * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
Vascular Hypotensive Disorders * 1  3/44 (6.82%)  3 0/5 (0.00%)  0 1/6 (16.67%)  1 4/55 (7.27%)  4
Vascular Malformations And Acquired Anomalies * 1  1/44 (2.27%)  1 0/5 (0.00%)  0 0/6 (0.00%)  0 1/55 (1.82%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
It is not required per Japan GCP. There is an agreement with the site, but not the individual investigator at the site.
Results Point of Contact
Name/Title: Hiroko Ookubo
Organization: Medtronic
Phone: 81367760811
Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT01437098     History of Changes
Other Study ID Numbers: MDT-2111
First Submitted: September 16, 2011
First Posted: September 20, 2011
Results First Submitted: October 2, 2015
Results First Posted: June 6, 2016
Last Update Posted: November 20, 2018