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

NCT05172960 | Recruiting DMC FDA Device

• 1 other identifier: 2021-05
• Study Type: interventional
• Target: 1,234
• Locations: 4 countries
• Sites: 65

Brief Summary

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).

Conditions

Aortic Stenosis, Severe

Keywords

Transcatheter aortic valve replacement (TAVR); Transcatheter aortic valve implantation (TAVI); SAPIEN X4/X4S

Outcome Measures

Primary Outcomes (1)

• Non-hierarchical composite of death and stroke

  The number of patients that died or had a stroke

  1 year

Secondary Outcomes (3)

• Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline

  1 year

• Paravalvular leak

  30 days

• New permanent pacemaker implantation

  30 days

Study Arms (3)

TAVR - Main Cohort

EXPERIMENTAL

Subjects will undergo transcatheter aortic valve replacement (TAVR)

Device: SAPIEN X4 THV

TAVR - Bicuspid Registry

EXPERIMENTAL

Subjects with bicuspid aortic valve morphology will undergo TAVR

Device: SAPIEN X4 THV

TAVR - X4S Registry

EXPERIMENTAL

Subjects will undergo transcatheter aortic valve replacement (TAVR)

Device: SAPIEN X4S

Interventions

SAPIEN X4 THV DEVICE

Implantation of the SAPIEN X4 valve

TAVR - Bicuspid Registry; TAVR - Main Cohort

SAPIEN X4S DEVICE

Implantation of the SAPIEN X4S valve

TAVR - X4S Registry

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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 planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (65)

Scripps Memorial Hospital La Jolla

La Jolla, California, 92037, United States

ACTIVE NOT RECRUITING

Kaiser Los Angeles

Los Angeles, California, 90027, United States

ACTIVE NOT RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

ACTIVE NOT RECRUITING

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

ACTIVE NOT RECRUITING

UC Davis Medical Center Sacramento

Sacramento, California, 95817, United States

ACTIVE NOT RECRUITING

Bay Area Structural Heart at Sutter Health

San Francisco, California, 94109, United States

ACTIVE NOT RECRUITING

Kaiser San Francisco Medical Center

San Francisco, California, 94115, United States

ACTIVE NOT RECRUITING

Stanford University

Stanford, California, 94305, United States

ACTIVE NOT RECRUITING

UC Health Northern Colorado (Medical Center of the Rockies)

Loveland, Colorado, 80538, United States

ACTIVE NOT RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

ACTIVE NOT RECRUITING

Naples Community Hospital Healthcare System

North Naples, Florida, 34102, United States

ACTIVE NOT RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

ACTIVE NOT RECRUITING

Emory University Atlanta

Atlanta, Georgia, 30322, United States

ACTIVE NOT RECRUITING

Rush University Medical Center Chicago

Chicago, Illinois, 60612, United States

ACTIVE NOT RECRUITING

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

RECRUITING

NorthShore University HealthSystem Research Institute Evanston

Evanston, Illinois, 60201, United States

ACTIVE NOT RECRUITING

Northwestern University Chicago

Evanston, Illinois, 60611, United States

ACTIVE NOT RECRUITING

Silver Cross Hospital

New Lenox, Illinois, 60541, United States

ACTIVE NOT RECRUITING

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

Carmel, Indiana, 46290, United States

ACTIVE NOT RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

ACTIVE NOT RECRUITING

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

ACTIVE NOT RECRUITING

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

ACTIVE NOT RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Henry Ford Hospital

Detroit, Michigan, 48202, United States

ACTIVE NOT RECRUITING

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

ACTIVE NOT RECRUITING

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

ACTIVE NOT RECRUITING

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

ACTIVE NOT RECRUITING

Washington University - Barnes-Jewish Hospital Saint Louis

St Louis, Missouri, 63110, United States

ACTIVE NOT RECRUITING

St. Patrick Hospital

Missoula, Montana, 59802, United States

ACTIVE NOT RECRUITING

Dartmouth-Hitchcock Medical Center, Hanover

Lebanon, New Hampshire, 03756, United States

ACTIVE NOT RECRUITING

Atlantic Health System Morristown

Morristown, New Jersey, 07960, United States

RECRUITING

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

ACTIVE NOT RECRUITING

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

ACTIVE NOT RECRUITING

University at Buffalo - Kaleida Health

Buffalo, New York, 14203, United States

ACTIVE NOT RECRUITING

Cornell Medical Center

New York, New York, 10021, United States

ACTIVE NOT RECRUITING

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Montefiore Medical Center

New York, New York, 10458, United States

ACTIVE NOT RECRUITING

Carolinas Health System

Charlotte, North Carolina, 28203, United States

ACTIVE NOT RECRUITING

Novant Health and Heart Vascular Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

The Christ Hospital

Cincinnati, Ohio, 45219, United States

ACTIVE NOT RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

ACTIVE NOT RECRUITING

Oklahoma Cardiovascular Research Group Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

ACTIVE NOT RECRUITING

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

RECRUITING

Kaiser Portland

Clackamas, Oregon, 97015, United States

RECRUITING

Providence Heart & Vascular Institute Portland

Portland, Oregon, 97225, United States

ACTIVE NOT RECRUITING

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, 17101, United States

COMPLETED

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

ACTIVE NOT RECRUITING

Methodist Le Bonheur Healthcare

Germantown, Tennessee, 38138, United States

ACTIVE NOT RECRUITING

Centennial Medical Center

Nashville, Tennessee, 37203, United States

ACTIVE NOT RECRUITING

Saint Thomas Health

Nashville, Tennessee, 37205, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

ACTIVE NOT RECRUITING

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

ACTIVE NOT RECRUITING

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

ACTIVE NOT RECRUITING

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

ACTIVE NOT RECRUITING

University of Texas Memorial Hermann

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

ACTIVE NOT RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

ACTIVE NOT RECRUITING

University of Washington Seattle

Seattle, Washington, 98195, United States

ACTIVE NOT RECRUITING

St. Andrews War Memorial Hospital

Spring Hill, Queensland, 4000, Australia

ACTIVE NOT RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

ACTIVE NOT RECRUITING

The Royal Melbourne Hospital

Parkville, 3050, Australia

ACTIVE NOT RECRUITING

St. Paul's Hospital System

Vancouver, British Columbia, V6E 1M7, Canada

ACTIVE NOT RECRUITING

Hamilton Health Services

Hamilton, Ontario, L8L 2X2, Canada

ACTIVE NOT RECRUITING

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

Québec, Quebec, G1V 4G5, Canada

ACTIVE NOT RECRUITING

Christchurch Hospital

Christchurch, 8011, New Zealand

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Tamim M. Nazif, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Rahul P. Sharma, MBBS

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edwards THV Clinical Affairs

CONTACT

949-250-2500; THV_CT.gov@Edwards.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: December 29, 2021
• Study Start: June 20, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2037
• Last Updated: July 8, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); AU (3); CA (3); US (58)