ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Trial details

Who runs it

Edwards Lifesciences

Trial code

NCT05172960

Record updated

24 September 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 with symptomatic, severe, calcific aortic stenosis (AS).Read full original descriptionShow less

Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve

The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4/X4S Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Inclusion: Severe, calcific AS; Native aortic annulus size suitable for SAPIEN X4 THV; NYHA functional class ≥ II; The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion: 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 (unless part of planned strategy for treatment of CAD). 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 (unless part of planned strategy for treatment of CAD); 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; Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI); 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; Aortic valve is unicuspid, bicuspid or non-calcified; Pre-existing mechanical or bioprosthetic valve in any position; Severe aortic regurgitation (> 3+); Severe mitral regurgitation (> 3+) or ≥ moderate mitral stenosis; Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months; Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation; Increased risk of coronary artery obstruction after THV implantation; Hypertrophic cardiomyopathy with subvalvular obstruction; Leukopenia, anemia, thrombocytopenia; Subject refuses blood products; BMI > 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 NCT05172960