PARTNER 3 Trial - Mitral Valve in Valve

A prospective, single-arm, multicenter clinical trial. This study will enroll patients with symptomatic heart disease due to a failing bioprosthetic mitral valve (stenosed, insufficient, or combined).

Inclusion criteria

• Failing surgically implanted bioprosthetic valve in the mitral position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
• Surgical bioprosthetic valve with a true internal diameter (True ID) of 16.5 mm to 28.5 mm.
• NYHA Functional Class ≥ II.
• Heart Team agrees the patient is intermediate risk (i.e. STS score of ≥3 and < 8).
• 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 as approved by the Institutional Review Board (IRB) / Ethics Committee (EC) of the respective clinical site.

Exclusion criteria

• Index valve has ≥ mild paravalvular regurgitation where the surgical bioprosthesis is not securely fixed in the native annulus or is not structurally intact as determined by transesophageal echocardiography (TEE).
• Surgical or transcatheter aortic valve placed so that extension into left ventricular outflow tract (LVOT) that may impinge on the mitral implant.
• Known residual mean gradient >10 mmHg at the end of the index procedure for implantation of the original surgical valve.
• Severe right ventricle (RV) dysfunction.
• Anatomical characteristics that would preclude safe access to the apex (transapical).
• Severe regurgitation or stenosis of any other valve.
• Severe lung disease (FEV1 < 50% predicted) or currently on home oxygen
• Severe pulmonary hypertension (e.g., PA systolic pressure ≥ 2/3 systemic pressure)
• Anatomical characteristics that would increase risk of LVOT obstruction (e.g., aortomitral angle, LVOT size, etc.).
• Evidence of an acute myocardial infarction ≤ 1 month (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 (PPM) or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
• Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation.
• Leukopenia (white blood count < 3000 cell/mL), anemia (hemoglobin < 9 g/dL), thrombocytopenia (blood platelet count < 50,000 cell/mL), 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 intervention/surgical procedures within one month (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 (HOCM).
• Left ventricular ejection fraction (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 (TIA) within 90 days of enrollment.
• Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of enrollment.
• Renal insufficiency (eGFR < 30 ml/min per the Cockcroft-Gault formula) and/or renal replacement therapy at the time of screening.
• Active bacterial endocarditis within 6 months (180 days) of the procedure.
• Patient refuses blood products.
• Estimated life expectancy < 24 months.
• Currently participating in an investigational drug or another device study. Note: Clinical trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
• Positive urine or serum pregnancy test in female subjects of childbearing potential.