ALLIANCE AVIV: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

Trial details

Who runs it

Edwards Lifesciences

Trial code

NCT05172973

Record updated

7 October 2026

Original description

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.Read full original descriptionShow less

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.

Inclusion: Failing aortic bioprosthetic valve demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency; Bioprosthetic valve 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: Surgical or transcatheter valve in the mitral position; Myocardial infarction within 30 days prior to the study procedure; Subjects with planned concomitant ablation for atrial fibrillation; Any surgical or transcatheter procedure within 30 days prior to the study procedure. Implantation of a permanent pacemaker or implantable cardioverter defibrillator 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; Inability to tolerate or condition precluding treatment with antithrombotic therapy; Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication; 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; Cardiac imaging evidence of intracardiac mass, thrombus or vegetation; Clinically significant coronary artery disease requiring revascularization; Renal insufficiency and/or renal replacement therapy; Hypercoagulable state or other condition that increases risk of thrombosis; Left ventricular ejection fraction < 20%; Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system; Failing valve has moderate or severe paravalvular regurgitation; Failing valve is unstable, rocking, or not structurally intact; Known severe patient-prosthesis mismatch or bioprosthetic valve with residual mean gradient > 20 mmHg at the end of the index procedure for implantation of the original valve; Increased risk of THV embolization; Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis; Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months; Increased risk of coronary artery obstruction after THV implantation; Hypertrophic cardiomyopathy with subvalvular obstruction; Leukopenia, anemia, thrombocytopenia; Subject refuses blood products; Body mass index > 50 kg/m2; Estimated life expectancy < 24 months; Female who is pregnant or lactating; Subject considered to be part of a vulnerable population.

ClinicalTrials.gov NCT05172973