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

Recruiting now · Not applicable

Conditions studied: Aortic Stenosis, Severe

In brief

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).

Key facts

Study ID

NCT05172960

Run by

Edwards Lifesciences

People needed

1234

Starts

2022-06-20

Expected to finish

2037-01-01

Last updated by the study team

2026-07-08

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 ejection fraction < 20%
• Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
• 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
• Myocardial infarction within 30 days prior to the study procedure
• Hypertrophic cardiomyopathy with subvalvular obstruction
• Subjects with planned concomitant ablation for atrial fibrillation
• Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
• 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
• 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

Where it is running

• Atlantic Health System Morristown — Morristown, New Jersey, United States (enrolling)
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States (enrolling)
• Kaiser Portland — Clackamas, Oregon, United States (enrolling)
• Alexian Brothers Hospital Network — Elk Grove Village, Illinois, United States (enrolling)
• Novant Health and Heart Vascular Institute — Charlotte, North Carolina, United States (enrolling)
• Saint Thomas Health — Nashville, Tennessee, United States (enrolling)
• Kaiser San Francisco Medical Center — San Francisco, California, United States
• Bay Area Structural Heart at Sutter Health — San Francisco, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Naples Community Hospital Healthcare System — North Naples, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory University Atlanta — Atlanta, Georgia, United States
• Rush University Medical Center Chicago — Chicago, Illinois, United States
• Hartford Hospital — Hartford, Connecticut, United States
• UC Davis Medical Center Sacramento — Sacramento, California, United States
• St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC — Carmel, Indiana, United States
• Silver Cross Hospital — New Lenox, Illinois, United States
• UC Health Northern Colorado (Medical Center of the Rockies) — Loveland, Colorado, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States
• Medstar Union Memorial Hospital — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Northwestern University Chicago — Evanston, Illinois, United States

Full record on ClinicalTrials.gov

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