PARTNER 3 Trial - Aortic Valve-in-Valve

Trial details

Who runs it

Edwards Lifesciences

Trial code

NCT03003299

Record updated

10 May 2024

Original description

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.Read full original descriptionShow less

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

Inclusion: 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: Surgical or transcatheter valve in the mitral position (mitral rings are not an exclusion); 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; 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; 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; Currently participating in an investigational drug or another device study; 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; Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation; 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; LVEF < 30%; Positive urine or serum pregnancy test in female subjects of childbearing potential; 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); Hypertrophic cardiomyopathy with obstruction; Active bacterial endocarditis within 180 days of the procedure; Patient refuses blood products; Estimated life expectancy < 24 months.

ClinicalTrials.gov NCT03003299