PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

Edwards Lifesciences

Status: Active, not recruiting

Conditions: Aortic Stenosis

Treatments: Procedure: SAVR; Device: SAPIEN 3 THV

Study type: Interventional

Funder types: Industry

Identifiers

NCT02675114

2015-08

Details and patient eligibility

About

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.

Full description

Prospective, randomized, controlled, multi-center trial. Patients having an operative mortality < 4% (low operative risk) for surgical aortic valve replacement will be randomized 1:1 to receive either transcatheter heart valve replacement (TAVR) with the Edwards SAPIEN 3 or aortic valve replacement with a commercially available surgical bioprosthetic valve. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 10 years.

A subset of PARTNER 3 randomized patients will be enrolled in the Actigraphy/Quality of Life. Additional patients will be enrolled in either the Bicuspid Registry, Underrepresented Populations Registry (UPR) or the Alternative Access Registry.

Enrollment: 1,000 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

Surgical aortic valve replacement (SAVR)

Active Comparator group

Treatment:

Procedure: SAVR

Transcatheter aortic valve replacement (TAVR)

Experimental group

Treatment:

Device: SAPIEN 3 THV