This study is in progress, not accepting new patients

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

a study on Aortic Stenosis

Summary

Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Richard Shemin

Description

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.

Official 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

Details

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.

Keywords

Aortic Stenosis, SAPIEN 3, cardiovascular disease, heart disease, Surgical aortic valve replacement (SAVR), Transcatheter aortic valve replacement (TAVR), Aortic Valve Stenosis, Pathologic Constriction, SAVR, SAPIEN 3 THV

Eligibility

You can join if…

  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.

You CAN'T join if...

  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.

Locations

  • University of California, Los Angeles/Ronald Reagan Medical Center
    Los Angeles California 90095 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States

Lead Scientist at UCLA

  • Richard Shemin
    Dr. Richard J. Shemin holds the Robert and Kelly Day Chair in Cardiothoracic Surgery.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT02675114
Study Type
Interventional
Participants
About 1000 people participating
Last Updated