Summary

Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This study will assess the safety and effectiveness of the SAPIEN 3 transcatheter heart valve in patients with a failing aortic surgical or transcatheter bioprosthetic valve.

Official Title

A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve

Keywords

Aortic Stenosis Cardiomyopathy, Hypertrophic SAPIEN 3 PARTNER 3 cardiovascular disease heart disease SAVR TAVR failing surgical valve failing bioprosthetic valve failing valve Cardiomyopathies Aortic Valve Stenosis Edwards SAPIEN 3 THV TAVR - Failing surgical valve TAVR - Failing transcatheter valve

Eligibility

You can join if…

  1. Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  2. Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
  3. NYHA Functional Class ≥ II.
  4. Heart Team agrees the patient is low to intermediate risk.
  5. Heart Team agrees valve implantation will likely benefit the patient.
  6. 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. Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
  2. Severe regurgitation (> 3+) or stenosis of any other valve
  3. Failing valve has moderate or severe paravalvular regurgitation
  4. Failing valve is unstable, rocking, or not structurally intact
  5. Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  6. Increased risk of embolization of THV
  7. Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
  8. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
  9. Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
  10. . Anatomical characteristics that would preclude safe access to the apex (Transapical)
  11. . Evidence of an acute myocardial infarction ≤ 30 days before enrollment
  12. . Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days prior to the index procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator is not considered an exclusion.
  13. . Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
  14. . Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  15. . Untreated clinically significant coronary artery disease requiring revascularization
  16. . Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
  17. . Emergency interventional/surgical procedures within 30 days prior to the procedure
  18. . Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
  19. . Hypertrophic cardiomyopathy with obstruction
  20. . LVEF < 30%
  21. . Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  22. . Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  23. . Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  24. . Stroke or transient ischemic attack within 90 days of enrollment
  25. . Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
  26. . Renal insufficiency and/or renal replacement therapy at the time of screening
  27. . Active bacterial endocarditis within 180 days of the procedure
  28. . Patient refuses blood products
  29. . Estimated life expectancy < 24 months
  30. . Positive urine or serum pregnancy test in female subjects of childbearing potential
  31. . Currently participating in an investigational drug or another device study

Locations

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States
  • Kaiser Permanente San Francisco withdrawn
    San Francisco California 94115 United States
  • Cedars Sinai Medical Center not yet accepting patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT03003299
Study Type
Interventional
Last Updated