Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05172960

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

Sponsor: Edwards Lifesciences

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

915

Start Date

2022-06-20

Completion Date

2034-12

Last Updated

2025-08-14

Healthy Volunteers

Conditions

Aortic Stenosis, Severe

Interventions

DEVICE

SAPIEN X4 THV

Implantation of the SAPIEN X4 valve

Inclusion Criteria: 1. Severe, calcific AS 2. Native aortic annulus size suitable for SAPIEN X4 THV 3. NYHA functional class ≥ II 4. The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system 2. Aortic valve is unicuspid, bicuspid or non-calcified 3. Pre-existing mechanical or bioprosthetic valve in any position 4. Severe aortic regurgitation (\> 3+) 5. Severe mitral regurgitation (\> 3+) or ≥ moderate mitral stenosis 6. Need for mitral, tricuspid or pulmonic valve intervention within the next 12 months 7. Left ventricular ejection fraction \< 20% 8. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant PVL after THV implantation 10. Increased risk of coronary artery obstruction after THV implantation 11. Myocardial infarction within 30 days prior to the study procedure 12. Hypertrophic cardiomyopathy with subvalvular obstruction 13. Subjects with planned concomitant ablation for atrial fibrillation 14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI) 15. 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. 16. 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) 17. Endocarditis within 180 days prior to the study procedure 18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure 19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure 20. Renal insufficiency and/or renal replacement therapy 21. Leukopenia, anemia, thrombocytopenia 22. Inability to tolerate or condition precluding treatment with antithrombotic therapy 23. Hypercoagulable state or other condition that increases risk of thrombosis 24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication 25. Subject refuses blood products 26. BMI \> 50 kg/m2 27. Estimated life expectancy \< 24 months 28. Female who is pregnant or lactating 29. Active SARS-CoV-2 infection or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments 30. Participating in another investigational drug or device study that has not reached its primary endpoint 31. Subject considered to be part of a vulnerable population

Locations (65)

Scripps Memorial Hospital La Jolla

La Jolla, California, United States

Kaiser Los Angeles

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

UC Davis Medical Center Sacramento

Sacramento, California, United States

Bay Area Structural Heart at Sutter Health

San Francisco, California, United States

Kaiser San Francisco Medical Center

San Francisco, California, United States

Stanford University

Stanford, California, United States

UC Health Northern Colorado (Medical Center of the Rockies)

Loveland, Colorado, United States

Hartford Hospital

Hartford, Connecticut, 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

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, United States

NorthShore University HealthSystem Research Institute Evanston

Evanston, Illinois, United States

Northwestern University Chicago

Evanston, Illinois, United States

Silver Cross Hospital

New Lenox, Illinois, United States

St. Vincent Medical Group, Inc./ St. Vincent Heart Center of Indiana, LLC

Carmel, Indiana, 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

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Saint Luke's Hospital

Kansas City, Missouri, United States

Washington University - Barnes-Jewish Hospital Saint Louis

St Louis, Missouri, United States

St. Patrick Hospital

Missoula, Montana, United States

Dartmouth-Hitchcock Medical Center, Hanover

Lebanon, New Hampshire, United States

Atlantic Health System Morristown

Morristown, New Jersey, United States

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

The Valley Hospital

Ridgewood, New Jersey, United States

University at Buffalo - Kaleida Health

Buffalo, New York, United States

Cornell Medical Center

New York, New York, United States

Columbia University Medical Center/NYPH

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Carolinas Health System

Charlotte, North Carolina, United States

Novant Health and Heart Vascular Institute

Charlotte, North Carolina, United States

The Christ Hospital

Cincinnati, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Oklahoma Cardiovascular Research Group Oklahoma City

Oklahoma City, Oklahoma, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

Kaiser Portland

Clackamas, Oregon, United States

Providence Heart & Vascular Institute Portland

Portland, Oregon, United States

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Methodist Le Bonheur Healthcare

Germantown, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

Saint Thomas Health

Nashville, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor Heart and Vascular Hospital

Dallas, Texas, United States

Medical City Dallas Hospital

Dallas, Texas, United States

HCA Houston Healthcare Medical Center

Houston, Texas, United States

University of Texas Memorial Hermann

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

University of Washington Seattle

Seattle, Washington, United States

St. Andrews War Memorial Hospital

Spring Hill, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

The Royal Melbourne Hospital

Parkville, Australia

St. Paul's Hospital System

Vancouver, British Columbia, Canada

Hamilton Health Services

Hamilton, Ontario, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Quebec- Universite Laval

Québec, Quebec, Canada

Christchurch Hospital

Christchurch, New Zealand

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (65)