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

Recruiting now · Not applicable

Conditions studied: Aortic Valve Insufficiency, Aortic Valve Stenosis

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 who are at high or greater risk with a failing aortic bioprosthetic valve.

Key facts

Study ID

NCT05172973

Run by

Edwards Lifesciences

People needed

200

Starts

2023-11-22

Expected to finish

2039-12-01

Last updated by the study team

2026-07-27

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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
• Surgical or transcatheter valve in the mitral position
• 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
• 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
• 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 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

Where it is running

• Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval — Québec, Quebec, Canada (enrolling)
• Bay Area Structural Heart at Sutter Health — San Francisco, California, United States (enrolling)
• Kaiser San Francisco — San Francisco, California, United States (enrolling)
• Stanford University Medical Center — Stanford, California, United States (enrolling)
• UC Health Medical Center of the Rockies — Loveland, Colorado, United States (enrolling)
• Naples Community Hospital Healthcare System — Naples, Florida, United States (enrolling)
• Emory University Atlanta — Atlanta, Georgia, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Northwestern University Chicago — Evanston, Illinois, United States (enrolling)
• Alexian Brothers Hospital Network — Lisle, Illinois, United States (enrolling)
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States (enrolling)
• MedStar Union Memorial Hospital — Baltimore, Maryland, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Henry Ford Hospital Detroit — Detroit, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Atlantic Health System Morristown — Morristown, New Jersey, United States (enrolling)
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
• The Valley Hospital — Ridgewood, New Jersey, United States (enrolling)
• University of Buffalo — Buffalo, New York, United States (enrolling)
• Cornelll University New York — New York, New York, United States (enrolling)
• Columbia University Medical Center / NYPH — New York, New York, United States (enrolling)
• Montefiore Medical Center — New York, New York, United States (enrolling)
• Rochester General Hospital — Rochester, New York, United States (enrolling)
• Carolinas Health System — Charlotte, North Carolina, United States (enrolling)
• Novant Health and Vascular Institute — Charlotte, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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