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PARTNER 3 Trial - Aortic Valve-in-Valve

About

Brief Summary

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
N/A
Maximum Age
N/A

Inclusion Criteria:

  • Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
  • Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
  • NYHA Functional Class ≥ II.
  • Heart Team agrees the patient is low to intermediate risk.
  • Heart Team agrees valve implantation will likely benefit the patient.
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion Criteria:

  • Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion)
  • Severe regurgitation (> 3+) or stenosis of any other valve
  • Failing valve has moderate or severe paravalvular regurgitation
  • Failing valve is unstable, rocking, or not structurally intact
  • Increased risk of coronary obstruction by prosthetic leaflets of the failing valve.
  • Increased risk of embolization of THV
  • Known bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve
  • Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (Transfemoral)
  • Anatomical characteristics that would preclude safe access to the ascending aorta (Transaortic)
  • Anatomical characteristics that would preclude safe access to the apex (Transapical)
  • Evidence of an acute myocardial infarction ≤ 30 days before enrollment
  • 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.
  • Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation
  • Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy or hypercoagulable states
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation, or mechanical heart assistance within 30 days of enrollment
  • Emergency interventional/surgical procedures within 30 days prior to the procedure
  • Any planned surgical, percutaneous coronary, or peripheral procedure to be performed within the 30-day follow-up from the procedure
  • Hypertrophic cardiomyopathy with obstruction
  • LVEF < 30%
  • Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
  • Inability to tolerate or condition precluding treatment with antithrombotic/anticoagulation therapy during or after the valve implant procedure
  • Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
  • Stroke or transient ischemic attack within 90 days of enrollment
  • Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment
  • Renal insufficiency and/or renal replacement therapy at the time of screening
  • Active bacterial endocarditis within 180 days of the procedure
  • Patient refuses blood products
  • Estimated life expectancy < 24 months
  • Positive urine or serum pregnancy test in female subjects of childbearing potential
  • Currently participating in an investigational drug or another device study

Join this Trial

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Study Stats
Protocol No.
17-000293
Category
Surgery
Contact
NANCY SATOU
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03003299
For detailed technical eligibility, visit ClinicalTrials.gov.