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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 : September 18, 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MDT-2111 TAVI Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.

Participant Flow:   Overall Study
    MDT-2111 TAVI
STARTED   55 
30 Days   51 
6 Months   47 
12 Months   45 
24 Months   42 
36 Months   36 
COMPLETED   42 
NOT COMPLETED   13 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
As Treated Subjects

Reporting Groups
  Description
MDT-2111 TAVI Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.

Baseline Measures
   MDT-2111 TAVI 
Overall Participants Analyzed 
[Units: Participants]
 55 
Age 
[Units: Years]
Mean (Standard Deviation)
 82.5  (5.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      38  69.1% 
Male      17  30.9% 
Region of Enrollment 
[Units: Participants]
 
Japan   55 
NYHA Class [1] 
[Units: Participants]
 
NYHA Class II   0 
NYHA Class III   49 
NYHA Class IV   6 
[1] 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] 
[Units: Percent]
Mean (Standard Deviation)
 8.0  (4.2) 
[1] 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] 
[Units: Percent]
Mean (Standard Deviation)
 21.5  (9.9) 
[1] 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) 
[Units: Cm²]
Mean (Standard Deviation)
 0.6  (0.1) 


  Outcome Measures

1.  Primary:   Composite Success of Improvement in New York Heart Association (NYHA) Class and a Performance Goal for Effective Orifice Area (EOA).   [ Time Frame: baseline and 6 months ]

2.  Secondary:   NYHA Classification Over Time   [ Time Frame: 30 days ]

3.  Secondary:   NYHA Classification Over Time   [ Time Frame: 6 months ]

4.  Secondary:   NYHA Classification Over Time   [ Time Frame: 12 Months ]

5.  Secondary:   NYHA Classification Over Time   [ Time Frame: 24 Months ]

6.  Secondary:   NYHA Classification Over Time   [ Time Frame: 36 Months ]

7.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 0 day to 30 days ]

8.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 0 day to 6 months ]

9.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 0 day to 12 months ]

10.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 0 day to 24 months ]

11.  Secondary:   Major Adverse Cardiovascular and Cerebrovascular Event (MACCE)   [ Time Frame: 0 day to 36 months ]

12.  Secondary:   Device Success as Defined in the Description.   [ Time Frame: after procedure or discharge ]

13.  Secondary:   Procedural Success, Defined as Device Success and Absence of In-hospital MACCE.   [ Time Frame: after procedure or discharge ]

14.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient   [ Time Frame: 30 days ]

15.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance- Mean Gradient   [ Time Frame: 6 months ]

16.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient   [ Time Frame: 12 months ]

17.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient   [ Time Frame: 24 months ]

18.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Mean Gradient   [ Time Frame: 36 months ]

19.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)   [ Time Frame: 30 days ]

20.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)   [ Time Frame: 6 months ]

21.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)   [ Time Frame: 12 months ]

22.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)   [ Time Frame: 24 months ]

23.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance- Effective Orifice Area (EOA)   [ Time Frame: 36 months ]

24.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: 30 days ]

25.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: 6 months ]

26.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: 12 months ]

27.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: 24 months ]

28.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Left Ventricular Ejection Fraction (LVEF)   [ Time Frame: 36 months ]

29.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)   [ Time Frame: 30 days ]

30.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)   [ Time Frame: 6 months ]

31.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)   [ Time Frame: 12 months ]

32.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)   [ Time Frame: 24 months ]

33.  Secondary:   Echocardiographic Assessment of Prosthetic Valve Performance - Total Aortic Valve Regurgitation (Transvalvular & Paravalvular) (Total AR)   [ Time Frame: 36 months ]

34.  Secondary:   Repeat Hospitalization   [ Time Frame: 0 day to 30 days ]

35.  Secondary:   Repeat Hospitalization   [ Time Frame: 0 day to 6 months ]

36.  Secondary:   Repeat Hospitalization   [ Time Frame: 0 day to 12 months ]

37.  Secondary:   Repeat Hospitalization   [ Time Frame: 0 day to 24 months ]

38.  Secondary:   Repeat Hospitalization   [ Time Frame: 0 day to 36 months ]

39.  Secondary:   Valve-related Deaths   [ Time Frame: 0 day to 30 days ]

40.  Secondary:   Valve-related Deaths   [ Time Frame: 0 day to 6 months ]

41.  Secondary:   Valve-Related Deaths   [ Time Frame: 0 day to 12 months ]

42.  Secondary:   Valve-related Deaths   [ Time Frame: 0 day to 24 months ]

43.  Secondary:   Valve-related Deaths   [ Time Frame: 0 day to 36 months ]

44.  Secondary:   Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)   [ Time Frame: Baseline to 30 days ]

45.  Secondary:   Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)   [ Time Frame: Baseline to 6 months ]

46.  Secondary:   Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)   [ Time Frame: Baseline to 12 months ]

47.  Secondary:   Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)   [ Time Frame: Baseline to 24 Months ]

48.  Secondary:   Quality of Life Assessment Using SF-36 Questionnaire - Physical Component Summary (Paired Change From Baseline) (Q of L)   [ Time Frame: Baseline to 36 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Hiroko Ookubo
Organization: Medtronic
phone: 81367760811
e-mail: hiroko.ookubo@medtronic.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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: September 18, 2018