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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01700439
Recruitment Status : Active, not recruiting
First Posted : October 4, 2012
Results First Posted : December 13, 2017
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Type Interventional
Study Design Allocation: N/A;   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
Hide 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
Hide 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.
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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
Hide 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%) 
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
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
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
Organization: Edwards Lifesciences, LLC
Phone: 949-250-2500 ext 0225
EMail: Andrey_Nersesov@edwards.com
Publications of Results:
Barnhart GR, Accola KD, Grossi EA, Woo YJ, Mumtaz MA, Sabik JF, Slachman FN, Patel HJ, Borger MA, Garrett HE Jr, Rodriguez E, McCarthy PM, Ryan WH, Duhay FG, Mack MJ, Chitwood WR Jr; TRANSFORM Trial Investigators. TRANSFORM (Multicenter Experience With Rapid Deployment Edwards INTUITY Valve System for Aortic Valve Replacement) US clinical trial: Performance of a rapid deployment aortic valve. J Thorac Cardiovasc Surg. 2017 Feb;153(2):241-251.e2. doi: 10.1016/j.jtcvs.2016.09.062. Epub 2016 Oct 15.
Romano MA, Koeckert M, Mumtaz MA, Slachman FN, Patel HJ, Chitwood WR Jr, Barnhart GR, Grossi EA; TRANSFORM Trial Investigators. Permanent Pacemaker Implantation After Rapid Deployment Aortic Valve Replacement. Ann Thorac Surg. 2018 Sep;106(3):685-690. doi: 10.1016/j.athoracsur.2018.03.055. Epub 2018 Apr 26.
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01700439    
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 30, 2020