PARTNER 3 Trial - Aortic Valve-in-Valve

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis, Aortic Stenosis, Severe

In brief

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.

Key facts

Study ID

NCT03003299

Run by

Edwards Lifesciences

People needed

125

Starts

2017-01-05

Expected to finish

2038-04-01

Last updated by the study team

2024-05-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• The Heart Hospital Baylor Plano — Dallas, Texas, United States (enrolling)
• The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Providence Heart & Vascular Institute — Portland, Oregon, United States (enrolling)
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States (enrolling)
• Medical City Dallas Hospital — Dallas, Texas, United States (enrolling)
• Cornell University — New York, New York, United States (enrolling)
• Columbia University Medical Center/ New York Presbyterian Hospital — New York, New York, United States (enrolling)
• Sutter Medical Center — Sacramento, California, United States (enrolling)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• UC Health Northern Colorado/Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Northwestern University Hospital — Chicago, Illinois, United States (enrolling)
• Washington University/ Barnes-Jewish Hospital — St Louis, Missouri, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Hartford Hospital — Hartford, Connecticut, United States (enrolling)
• Newark Beth Israel — Newark, New Jersey, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• Winthrop University Hospital — Mineola, New York, United States (enrolling)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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