ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral

This is a prospective, single arm, multicenter, pivotal study.

Inclusion criteria

• Failing mitral surgical bioprosthetic valve or a failing native mitral valve with an annuloplasty ring demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency
• Bioprosthetic surgical valve or native mitral annulus size suitable for SAPIEN X4 THV
• NYHA functional class ≥ II
• Heart Team agrees the subject is at high or greater surgical risk
• The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion criteria

• Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
• Interatrial septum or left atrium not suitable for transcatheter transseptal access
• Failing valve has mild or greater paravalvular regurgitation
• Failing valve is unstable, rocking, or not structurally intact
• Annuloplasty ring dehiscence
• Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 10 mmHg at the end of the index procedure for implantation of the original valve
• Annuloplasty ring type not favorable for THV implantation
• Increased risk of THV embolization
• Anatomical characteristics that would increase risk of left ventricular outflow tract (LVOT) obstruction
• Surgical or transcatheter aortic valve extending into LVOT that may impinge on the mitral implant
• Severe right ventricle (RV) dysfunction
• Severe regurgitation or stenosis of any other valve
• Need for aortic, tricuspid, or pulmonic valve intervention within the next 12 months
• Left ventricular ejection fraction < 20%
• Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
• Myocardial infarction within 30 days prior to the study procedure
• Hypertrophic cardiomyopathy with subvalvular obstruction
• Subjects with planned concomitant ablation for atrial fibrillation
• Clinically significant coronary artery disease requiring revascularization
• Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
• Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure
• Endocarditis within 180 days prior to the study procedure
• Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
• Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
• Renal insufficiency and/or renal replacement therapy
• Leukopenia, anemia, thrombocytopenia
• Inability to tolerate or condition precluding treatment with antithrombotic therapy
• Hypercoagulable state or other condition that increases risk of thrombosis
• Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
• Subject refuses blood products
• Body mass index > 50 kg/m2
• Estimated life expectancy < 24 months
• Female who is pregnant or lactating
• Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
• Participating in another investigational drug or device study that has not reached its primary endpoint
• Subject considered to be part of a vulnerable population