Open Actively Recruiting
PARTNER 3 Trial - Aortic Valve-in-Valve
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.
- 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.
- 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
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