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Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve (TRANSFORM™)

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ClinicalTrials.gov Identifier: NCT01700439
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Results First Posted : December 13, 2017
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Aortic Valve Stenosis
Aortic Valve Stenosis With Insufficiency
Regurgitation, Aortic Valve
Aortic Valve Incompetence
Intervention Device: EDWARDS INTUITY valve
Enrollment 934
Recruitment Details  
Pre-assignment Details 934 participants were considered enrolled; however, data are only available for 889 participants.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description Subjects who received an INTUITY study surgical aortic heart valve.
Period Title: Overall Study
Started 889
Study Valve Group 839 [1]
Discharge 831
3 Month 778
1 Year 573
2 Year 215
Completed 0
Not Completed 889
[1]
Received the Edwards INTUITY surgical aortic heart valve.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description Subjects who received an Edwards INTUITY surgical aortic heart valve.
Overall Number of Baseline Participants 839
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 839 participants
73.5  (8.3)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 839 participants
Female
298
  35.5%
Male
541
  64.5%
[1]
Measure Analysis Population Description: 839 are analyzed to date
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 839 participants
Hispanic or Latino
3
   0.4%
Not Hispanic or Latino
773
  92.1%
Unknown or Not Reported
63
   7.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 839 participants
934
1.Primary Outcome
Title Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Hide Description Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:[(Number of late adverse events/sum of late patient years) x 100]
Time Frame Events occurring ≥ 31 days and up through 2 years post-implant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an Edwards INTUITY surgical aortic heart valve.
Overall Number of Participants Analyzed 839
Measure Type: Number
Unit of Measure: Percentage of events/late patient years
All cause mortality 3.0
Valve related mortality 1.1
Study valve reoperation 0.9
Study valve explant 0.5
Thromboembolism 2.6
Valve thrombosis 0.0
Endocarditis 0.0
All bleeding 5.1
Major bleeding 2.5
All paravalvular leak 1.8
Major paravalvular leak (PVL) 0.8
Hemolysis 0.2
Non-structural valve dysfunction other than PVL 0.4
Valve migration/embolization 0.0
Valve malposition 0.1
Valve instability 0.1
Valve dislodgement 0.0
Structural valve deterioration 0.0
Conduction defects 0.6
Conduction defects with permanent pacemaker 0.0
Conduction defects without permanent pacemaker 0.6
2.Secondary Outcome
Title Percentage of Subjects With Edwards INTUITY Surgical Aortic Heart Valve Device Technical Success
Hide Description Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with maximum of two attempts and subject leaving the operating room (OR) with valve in place.
Time Frame Day of procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for enrolled subjects where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an Edwards INTUITY surgical aortic heart valve.
Overall Number of Participants Analyzed 888
Measure Type: Number
Unit of Measure: Percentage of subjects
94.5
3.Secondary Outcome
Title Percentage of Subjects With Edwards INTUITY Surgical Heart Valve Procedural Success
Hide Description Procedural success is defined as device technical success followed by the absence of adverse events resulting in device reoperation implant of permanent pacemaker (with baseline sinus rhythm and no other pre-existing conduction issues), or valve-related death within discharge or 10 days post index procedure, whichever comes first.
Time Frame Day of procedure through discharge or 10 days post index procedure, whichever comes first.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for enrolled subjects where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an Edwards INTUITY surgical aortic heart valve.
Overall Number of Participants Analyzed 886
Measure Type: Number
Unit of Measure: Percentage of subjects
94.1
4.Secondary Outcome
Title Average Amount of Time Subject Spent on Cardiopulmonary Bypass
Hide Description Surgical and hospitalization factors - Cardiopulmonary bypass time
Time Frame Day of procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data is not available for two subjects.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 837
Mean (Standard Deviation)
Unit of Measure: Minutes
86.2  (37.5)
5.Secondary Outcome
Title Average Subject Time on Cardiopulmonary Cross Clamp
Hide Description Surgical and hospitalization factors - Cardiopulmonary cross clamp time
Time Frame Day of procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data is not available for 3 subjects.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 836
Mean (Standard Deviation)
Unit of Measure: Minutes
64.9  (29.7)
6.Secondary Outcome
Title Average Number of Days Subjects Were in the Intensive Care Unit (ICU)
Hide Description Length of time surgical subjects were in the intensive care unit (ICU) after their heart valve replacement procedure.
Time Frame Day of procedure through discharge from the hospital
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data is not available for 5 subjects.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 834
Mean (Standard Deviation)
Unit of Measure: Days
3.1  (3.8)
7.Secondary Outcome
Title Subject’s Percentage of Change at 1 Year From Baseline in New York Heart Association (NYHA) Class
Hide Description

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity.

Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Symptoms of heart failure or the anginal syndrome may be present even at rest.

Time Frame Baseline and one year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 546
Measure Type: Count of Participants
Unit of Measure: Participants
Improved at 1 Year
399
  73.1%
Stayed the Same at 1 Year
129
  23.6%
Worsened at 1 Year
18
   3.3%
8.Secondary Outcome
Title Subject’s Average Gradient Measurements at 1 Year
Hide Description Hemodynamic performance - Mean and peak gradients evaluated by echocardiography
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 509
Mean (Standard Deviation)
Unit of Measure: mmHg
Mean Gradient 10.3  (3.8)
Peak Gradient 18.8  (7.0)
9.Secondary Outcome
Title Subject’s Effective Orifice Area (EOA) Measurement at 1 Year
Hide Description Hemodynamic performance - Effective Orifice Area (EOA) evaluated by echocardiography
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 491
Mean (Standard Deviation)
Unit of Measure: Centimeters squared
1.7  (0.3)
10.Secondary Outcome
Title Subject’s Effective Orifice Area Index (EOAI) Measurement at 1 Year
Hide Description Hemodynamic performance - Effective Orifice Area Index evaluated by echocardiography
Time Frame 1 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 488
Mean (Standard Deviation)
Unit of Measure: centimeters squared/meters squared
0.8  (0.2)
11.Secondary Outcome
Title Subject’s Performance Index Measurement at 1 Year
Hide Description Hemodynamic performance - Performance Index evaluated by echocardiography
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 491
Mean (Standard Deviation)
Unit of Measure: Centimeters squared/meters squared
0.9  (0.1)
12.Secondary Outcome
Title Subject’s Cardiac Output Measurement at 1 Year
Hide Description Hemodynamic performance - Cardiac Output evaluated by echocardiography
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 501
Mean (Standard Deviation)
Unit of Measure: Liters/minutes
4.9  (1.0)
13.Secondary Outcome
Title Subject’s Cardiac Index Measurement at 1 Year
Hide Description Hemodynamic performance - Cardiac index evaluated by echocardiography
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 497
Mean (Standard Deviation)
Unit of Measure: Liters/minutes/meters squared
2.4  (0.5)
14.Secondary Outcome
Title Amount of Aortic Valvular Regurgitation in Subjects at 1 Year by Valve Size
Hide Description Hemodynamic performance - Aortic valvular regurgitation evaluated by echocardiography
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available. Each subject can only receive one valve and results are presented by valve size. The number of participants in each of the valve sizes totals up to the overall number analyzed.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 521
Measure Type: Count of Participants
Unit of Measure: Participants
Valve size - 19 mm Number Analyzed 38 participants
None (0)/Trival (+1)
33
  86.8%
Mild (+2)
5
  13.2%
Moderate (+3)
0
   0.0%
Severe (+4)
0
   0.0%
Valve size - 21 mm Number Analyzed 118 participants
None (0)/Trival (+1)
114
  96.6%
Mild (+2)
3
   2.5%
Moderate (+3)
1
   0.8%
Severe (+4)
0
   0.0%
Valve size - 23 mm Number Analyzed 166 participants
None (0)/Trival (+1)
148
  89.2%
Mild (+2)
13
   7.8%
Moderate (+3)
5
   3.0%
Severe (+4)
0
   0.0%
Valve size - 25 mm Number Analyzed 137 participants
None (0)/Trival (+1)
122
  89.1%
Mild (+2)
14
  10.2%
Moderate (+3)
0
   0.0%
Severe (+4)
1
   0.7%
Valve size - 27 mm Number Analyzed 62 participants
None (0)/Trival (+1)
58
  93.5%
Mild (+2)
3
   4.8%
Moderate (+3)
0
   0.0%
Severe (+4)
1
   1.6%
15.Other Pre-specified Outcome
Title Subject’s Average Score at Baseline and 1 Year on the Quality of Life Survey
Hide Description The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. The SF-12 questionnaire scale ranges from 100, which reflects the best health status to 0, which reflects the worst health status.
Time Frame Baseline and one year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 526
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Mental Health - Baseline 51.3  (9.9)
Mental Health - 1 year follow-up 54.3  (8.6)
Physical Health - Baseline 41.8  (10.2)
Physical Health - 1 year follow-up 47.6  (9.7)
16.Other Pre-specified Outcome
Title Subject’s Average White Blood Cell Count at 1 Year
Hide Description Laboratory analysis of White Blood Cell Count on blood drawn from subject.
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 538
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/microliters
7.32  (3.1)
17.Other Pre-specified Outcome
Title Subject’s Average Red Blood Cell Count at 1 Year
Hide Description Laboratory analysis of Red Blood Cell Count of blood drawn from subject.
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 538
Mean (Standard Deviation)
Unit of Measure: 10^6 cells/microliters
4.44  (0.5)
18.Other Pre-specified Outcome
Title Subject’s Average Hematocrit Percentage at 1 Year
Hide Description Laboratory analysis of Hematocrit of blood drawn from subject.
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 538
Mean (Standard Deviation)
Unit of Measure: Percentage of RBC
40.1  (4.3)
19.Other Pre-specified Outcome
Title Subject’s Average Hemoglobin Percentage at 1 Year
Hide Description Laboratory analysis of Hemoglobin of blood drawn from subject.
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 538
Mean (Standard Deviation)
Unit of Measure: g/dL
13.29  (1.6)
20.Other Pre-specified Outcome
Title Subject’s Average Plasma Free Hemoglobin at 1 Year
Hide Description Laboratory Analysis of Plasma Free Hemoglobin of blood drawn from subject.
Time Frame 1 Year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This outcome is reported for subjects who received an Edwards INTUITY surgical aortic heart valve where data is available.
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description:
Subjects who received an INTUITY study surgical aortic heart valve.
Overall Number of Participants Analyzed 466
Mean (Standard Deviation)
Unit of Measure: mg/dL
12.23  (13.0)
Time Frame Events occurring from the day of aortic heart valve surgery through 2 years post implant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Edwards INTUITY Surgical Aortic Heart Valve
Hide Arm/Group Description Subjects who received an INTUITY study surgical aortic heart valve.
All-Cause Mortality
Edwards INTUITY Surgical Aortic Heart Valve
Affected / at Risk (%)
Total   25/839 (2.98%) 
Show Serious Adverse Events Hide Serious Adverse Events
Edwards INTUITY Surgical Aortic Heart Valve
Affected / at Risk (%)
Total   533/839 (63.53%) 
Blood and lymphatic system disorders   
Anemia - Bleeding Related - Minor   30/839 (3.58%) 
ANEMIA - BLEEDING RELATED - MAJOR   22/839 (2.62%) 
THROMBOCYTOPENIA - NON-HEPARIN INDUCED   18/839 (2.15%) 
BLEEDING - CARDIOVASCULAR - MAJOR   17/839 (2.03%) 
ANEMIA - NON-BLEEDING RELATED   13/839 (1.55%) 
BLEEDING - CARDIOVASCULAR - MINOR   9/839 (1.07%) 
BLEEDING - GASTROINTESTINAL UPPER - MAJOR   7/839 (0.83%) 
BLOOD SEPSIS   7/839 (0.83%) 
BLEEDING - GASTROINTESTINAL LOWER - MINOR   6/839 (0.72%) 
BLEEDING - GASTROINTESTINAL LOWER - MAJOR   5/839 (0.60%) 
BLOOD/LYMPHATIC - OTHER   5/839 (0.60%) 
THROMBOCYTOPENIA - HEPARIN INDUCED (HIT)   4/839 (0.48%) 
BLEEDING - GASTROINTESTINAL UPPER - MINOR   3/839 (0.36%) 
BLEEDING - GENITOURINARY - MINOR   3/839 (0.36%) 
BLEEDING - NEUROLOGICAL - MAJOR (E.G. CVA)   2/839 (0.24%) 
BLEEDING - PULMONARY/RESPIRATORY - MAJOR (E.G. HEMOTHORAX)   2/839 (0.24%) 
BLEEDING - GENITOURINARY - MAJOR   1/839 (0.12%) 
BLEEDING - MUSCULOSKELETAL/DERMATOLOGICAL - MINOR (E.G. ECCHYMOSIS)   1/839 (0.12%) 
BLEEDING - PERIPHERAL VASCULAR - MAJOR (E.G. NOSEBLEEDS; HEMATOMAS)   1/839 (0.12%) 
BLEEDING - PULMONARY/RESPIRATORY - MINOR (E.G. HEMOTHORAX)   1/839 (0.12%) 
Cardiac disorders   
ARRHYTHMIA - AV BLOCK - 3RD DEGREE   77/839 (9.18%) 
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)   63/839 (7.51%) 
ARRHYTHMIA - PERSISTENT ATRIAL FIBRILLATION   49/839 (5.84%) 
ARRHYTHMIA - ATRIAL FLUTTER   24/839 (2.86%) 
ARRHYTHMIA - OTHER   23/839 (2.74%) 
ARRHYTHMIA - BRADYCARDIA   16/839 (1.91%) 
ARRHYTHMIA - AV BLOCK - 2ND DEGREE   9/839 (1.07%) 
ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT   9/839 (1.07%) 
ARRHYTHMIA - TACHY-BRADYCARDIA   7/839 (0.83%) 
ARRHYTHMIA - TACHYCARDIA - VENTRICULAR   6/839 (0.72%) 
ARRHYTHMIA - AV BLOCK - 1ST DEGREE   4/839 (0.48%) 
ARRHYTHMIA - TACHYCARDIA - NON-VENTRICULAR   4/839 (0.48%) 
ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT   2/839 (0.24%) 
ARRHYTHMIA - SUPRAVENTRICULAR TACHYCARDIA (SVT)   2/839 (0.24%) 
ARRHYTHMIA - PAROXYSMAL ATRIAL TACHYCARDIA (PAT)   1/839 (0.12%) 
ARRHYTHMIA - PERMANENT ATRIAL FIBRILLATION   1/839 (0.12%) 
CARDIOVASCULAR - OTHER   40/839 (4.77%) 
HEART FAILURE - ACUTE   26/839 (3.10%) 
HYPOTENSION   18/839 (2.15%) 
HEART FAILURE - CHRONIC (CHF)   17/839 (2.03%) 
PERICARDIAL EFFUSION - MAJOR   13/839 (1.55%) 
CARDIAC ARREST   10/839 (1.19%) 
HYPERTENSION - SYSTEMIC   8/839 (0.95%) 
CARDIOGENIC SHOCK   7/839 (0.83%) 
ANGINA, UNSTABLE   4/839 (0.48%) 
MYOCARDIAL INFARCTION   4/839 (0.48%) 
PERICARDIAL TAMPONADE   4/839 (0.48%) 
PERICARDITIS   4/839 (0.48%) 
ANGINA, STABLE   3/839 (0.36%) 
AORTIC DISSECTION   3/839 (0.36%) 
PERICARDIAL EFFUSION - MINOR   3/839 (0.36%) 
CARDIAC DECOMPENSATION   2/839 (0.24%) 
ENDOCARDITIS   1/839 (0.12%) 
PERFORATION - VENTRICULAR   1/839 (0.12%) 
REGURGITATION - TRICUSPID-CENTRAL/TRANSVALVULAR +4   2/839 (0.24%) 
REGURGITATION - AORTIC-CENTRAL/TRANSVALVULAR +4   1/839 (0.12%) 
REGURGITATION - MITRAL-CENTRAL/TRANSVALVULAR +4   1/839 (0.12%) 
REGURGITATION - MITRAL-INDETERMINATE +4   1/839 (0.12%) 
THROMBOEMBOLIC EVENT - STROKE   22/839 (2.62%) 
THROMBOEMBOLIC EVENT - TRANSIENT ISCHEMIC ATTACK (TIA)   13/839 (1.55%) 
THROMBOEMBOLIC EVENT - OTHER - CENTRAL - NO PARESIS   1/839 (0.12%) 
Eye disorders   
VISION DISORDER   9/839 (1.07%) 
Gastrointestinal disorders   
GASTROINTESTINAL - OTHER   40/839 (4.77%) 
BILIARY (GALLBLADDER)   8/839 (0.95%) 
GASTROINTESTINAL - INFECTION   7/839 (0.83%) 
PANCREATIC COMPLICATION   5/839 (0.60%) 
HEPATIC COMPLICATION - OTHER   1/839 (0.12%) 
LIVER FAILURE - ACUTE   1/839 (0.12%) 
General disorders   
NSD - PARAVALVULAR LEAK +3   4/839 (0.48%) 
NSD - PARAVALVULAR LEAK +4   2/839 (0.24%) 
NSD - PARAVALVULAR LEAK WITH HEMOLYSIS   2/839 (0.24%) 
NSD - PARAVALVULAR LEAK +2   1/839 (0.12%) 
NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION   76/839 (9.06%) 
CANCER - NEWLY DIAGNOSED   12/839 (1.43%) 
FEVER - UNKNOWN ORIGIN   5/839 (0.60%) 
MULTI-SYSTEM ORGAN FAILURE   4/839 (0.48%) 
CANCER - PROGRESSION OF UNDERLYING DISEASE   2/839 (0.24%) 
ALLERGIC REACTION - MEDICATION RELATED   1/839 (0.12%) 
Musculoskeletal and connective tissue disorders   
MUSCULAR SKELETAL/DERMATOLOGIC - OTHER   39/839 (4.65%) 
BONE FRACTURE/BREAK   15/839 (1.79%) 
WOUND INFECTION - OTHER   14/839 (1.67%) 
INFECTION/INFLAMMATION - OTHER   13/839 (1.55%) 
STERNAL WOUND/THORACIC INFECTION   10/839 (1.19%) 
Psychiatric disorders   
PSYCHIATRIC - OTHER   8/839 (0.95%) 
Renal and urinary disorders   
RENAL FAILURE - ACUTE   22/839 (2.62%) 
URINARY TRACT INFECTION (UTI)   17/839 (2.03%) 
GENITOURINARY - OTHER   11/839 (1.31%) 
RENAL - OTHER   9/839 (1.07%) 
RENAL DYSFUNCTION   5/839 (0.60%) 
Respiratory, thoracic and mediastinal disorders   
RESPIRATORY FAILURE - OTHER   25/839 (2.98%) 
PLEURAL EFFUSION - RIGHT   24/839 (2.86%) 
PLEURAL EFFUSION - BILATERAL   20/839 (2.38%) 
RESPIRATORY INFECTION - PNEUMONIA   20/839 (2.38%) 
PLEURAL EFFUSION - LEFT   15/839 (1.79%) 
PULMONARY/RESPIRATORY - OTHER   12/839 (1.43%) 
RESPIRATORY DYSFUNCTION/INSUFFICIENCY   11/839 (1.31%) 
RESPIRATORY FAILURE - PNEUMONIA   11/839 (1.31%) 
HYPOXEMIA   8/839 (0.95%) 
PNEUMOTHORAX   7/839 (0.83%) 
RESPIRATORY FAILURE - COPD   6/839 (0.72%) 
RESPIRATORY FAILURE - PNEUMOTHORAX   5/839 (0.60%) 
RESPIRATORY INFECTION - UPPER (URI)   5/839 (0.60%) 
PULMONARY EDEMA   4/839 (0.48%) 
PULMONARY EMBOLISM - BILATERAL   4/839 (0.48%) 
PULMONARY EMBOLISM - RIGHT   3/839 (0.36%) 
RESPIRATORY FAILURE - ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)   3/839 (0.36%) 
RESPIRATORY FAILURE - ASTHMA   2/839 (0.24%) 
ATELECTASIS   1/839 (0.12%) 
PULMONARY EMBOLISM - LEFT   1/839 (0.12%) 
RESPIRATORY FAILURE - HEMOTHORAX   1/839 (0.12%) 
Vascular disorders   
VASCULAR - OTHER   17/839 (2.03%) 
VASCULAR - DEEP VEIN THROMBOSIS (DVT)   9/839 (1.07%) 
VASCULAR - ACCESS SITE COMPLICATION   2/839 (0.24%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Edwards INTUITY Surgical Aortic Heart Valve
Affected / at Risk (%)
Total   800/839 (95.35%) 
Blood and lymphatic system disorders   
THROMBOCYTOPENIA - NON-HEPARIN INDUCED   409/839 (48.75%) 
BLOOD/LYMPHATIC - OTHER   200/839 (23.84%) 
ANEMIA - BLEEDING RELATED - MINOR   174/839 (20.74%) 
ANEMIA - NON-BLEEDING RELATED   52/839 (6.20%) 
ANEMIA - BLEEDING RELATED - MAJOR   45/839 (5.36%) 
Cardiac disorders   
ARRHYTHMIA - PAROXYSMAL ATRIAL FIBRILLATION (PAF)   239/839 (28.49%) 
ARRHYTHMIA - BUNDLE BRANCH BLOCK - LEFT   234/839 (27.89%) 
ARRHYTHMIA - AV BLOCK - 1ST DEGREE   159/839 (18.95%) 
ARRHYTHMIA - OTHER   159/839 (18.95%) 
ARRHYTHMIA - BRADYCARDIA   97/839 (11.56%) 
ARRHYTHMIA - BUNDLE BRANCH BLOCK - RIGHT   59/839 (7.03%) 
HYPOTENSION   141/839 (16.81%) 
CARDIOVASCULAR - OTHER   76/839 (9.06%) 
HYPERTENSION - SYSTEMIC   49/839 (5.84%) 
Gastrointestinal disorders   
GASTROINTESTINAL - OTHER   66/839 (7.87%) 
General disorders   
NONSPECIFIC, UNKNOWN, OR OTHER BODY SYSTEM - OTHER COMPLICATION   153/839 (18.24%) 
Musculoskeletal and connective tissue disorders   
MUSCULAR SKELETAL/DERMATOLOGIC - OTHER   74/839 (8.82%) 
Psychiatric disorders   
PSYCHIATRIC - OTHER   45/839 (5.36%) 
Renal and urinary disorders   
URINARY TRACT INFECTION (UTI)   48/839 (5.72%) 
Respiratory, thoracic and mediastinal disorders   
ATELECTASIS   309/839 (36.83%) 
PLEURAL EFFUSION - BILATERAL   54/839 (6.44%) 
Indicates events were collected by systematic assessment
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.
PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation, but data analyses of site-specific results can occur only in intervals as specified in the CTA. Publication/presentation of the PI’s site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.
Results Point of Contact
Name/Title: Mary Edwards, VP Clinical and Regulatory Affairs, HVT
Organization: Edwards Lifesciences, LLC
Phone: 949-250-2500 ext 1536
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01700439     History of Changes
Other Study ID Numbers: 2011-02
First Submitted: September 19, 2012
First Posted: October 4, 2012
Results First Submitted: September 22, 2017
Results First Posted: December 13, 2017
Last Update Posted: March 14, 2018