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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02675114




Registration number
NCT02675114
Ethics application status
Date submitted
22/01/2016
Date registered
5/02/2016
Date last updated
30/11/2023

Titles & IDs
Public title
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
Scientific title
A Prospective, Randomized, Controlled, Multi-Center Study to Establish the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients Who Have Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement
Secondary ID [1] 0 0
2015-08
Universal Trial Number (UTN)
Trial acronym
P3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - SAVR
Treatment: Devices - SAPIEN 3 THV

Active Comparator: Surgical aortic valve replacement (SAVR) -

Experimental: Transcatheter aortic valve replacement (TAVR) -


Treatment: Surgery: SAVR
SAVR with a commercially available bioprosthetic valve.

Treatment: Devices: SAPIEN 3 THV
TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
New Onset Atrial Fibrillation
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
Length of Index Hospitalization
Timepoint [2] 0 0
Discharge (expected average of 7 days)
Secondary outcome [3] 0 0
Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease = 10 Points
Timepoint [3] 0 0
30 days
Secondary outcome [4] 0 0
Death or Stroke
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
All Stroke
Timepoint [5] 0 0
30 days

Eligibility
Key inclusion criteria
1. Severe, calcific aortic stenosis

2. New York Heart Association Functional Class = 2 OR exercise tolerance test that
demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR
asymptomatic with Left Ventricular Ejection Fraction (LVEF) <50%

3. Heart team agrees the patient has a risk of operative mortality and has an Society of
Thoracic Surgeons (STS) score < 4

4. The study patient has been informed of the nature of the study, agrees to its
provisions and has provided written informed consent.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm transcatheter
heart valve

2. Iliofemoral vessel characteristics that would preclude safe passage of the introducer
sheath

3. Evidence of an acute myocardial infarction = 30 days before randomization

4. Aortic valve is unicuspid, bicuspid, or non-calcified

5. Severe aortic regurgitation (>3+)

6. Severe mitral regurgitation (>3+) = moderate stenosis

7. Pre-existing mechanical or bioprosthetic valve in any position

8. Complex coronary artery disease:

1. Unprotected left main coronary artery

2. Syntax score > 32

3. Heart Team assessment that optimal revascularization cannot be performed

9. Symptomatic carotid or vertebral artery disease or successful treatment of carotid
stenosis within 30 days of randomization

10. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy,
or hypercoagulable states

11. Hemodynamic or respiratory instability requiring inotropic support, mechanical
ventilation or mechanical heart assistance within 30 days of randomization

12. Hypertrophic cardiomyopathy with obstruction

13. Ventricular dysfunction with LVEF < 30%

14. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation

15. Inability to tolerate or condition precluding treatment with
antithrombotic/anticoagulation therapy during or after the valve implant procedure

16. Stroke or transient ischemic attack within 90 days of randomization

17. Renal insufficiency and/or renal replacement therapy at the time of screening.

18. Active bacterial endocarditis within 180 days of randomization

19. Severe lung disease or currently on home oxygen

20. Severe pulmonary hypertension

21. History of cirrhosis or any active liver disease

22. Significant frailty as determined by the Heart Team

23. Significant abdominal or thoracic aortic disease that would preclude safe passage of
the delivery system or cannulation and aortotomy for surgical aortic valve replacement

24. Hostile chest or conditions or complications from prior surgery that would preclude
safe reoperation

25. Patient refuses blood products

26. Body mass index > 50 kg/m2

27. Estimated life expectancy < 24 months

28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately
treated with pre-medication

29. Immobility that would prevent completion of study procedures

30. Patient is not a candidate for both arms of the study

31. Currently participating in an investigational drug or another device study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2029
Actual
Sample size
Target
Accrual to date
Final
1000
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Hawaii
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maine
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Hampshire
Country [20] 0 0
United States of America
State/province [20] 0 0
New Jersey
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Oklahoma
Country [25] 0 0
United States of America
State/province [25] 0 0
Oregon
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Canada
State/province [33] 0 0
Vancouver
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Miyagi
Country [36] 0 0
Japan
State/province [36] 0 0
Osaka
Country [37] 0 0
Japan
State/province [37] 0 0
Tokyo
Country [38] 0 0
New Zealand
State/province [38] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve
(THV) in patients with severe, calcific aortic stenosis who are at low operative risk for
standard aortic valve replacement.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02675114
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin B Leon, MD, FACC
Address 0 0
Columbia University Medical Center/ New York Presbyterian Hospital, NY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02675114