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

NCT05172960 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2021-05
• Study Type: interventional
• Target: 915
• Locations: 4 countries
• Sites: 65

Brief 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).

Conditions

Aortic Stenosis, Severe

Keywords

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

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 (2)

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

Interventions

SAPIEN X4 THV DEVICE

Implantation of the SAPIEN X4 valve

TAVR - Bicuspid Registry; TAVR - Main Cohort

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

Location

Kaiser Los Angeles

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

UC Davis Medical Center Sacramento

Sacramento, California, 95817, United States

Location

Bay Area Structural Heart at Sutter Health

San Francisco, California, 94109, United States

Location

Kaiser San Francisco Medical Center

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

UC Health Northern Colorado (Medical Center of the Rockies)

Loveland, Colorado, 80538, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Naples Community Hospital Healthcare System

North Naples, Florida, 34102, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Atlanta

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center Chicago

Chicago, Illinois, 60612, United States

Location

Alexian Brothers Hospital Network

Elk Grove Village, Illinois, 60007, United States

Location

NorthShore University HealthSystem Research Institute Evanston

Evanston, Illinois, 60201, United States

Location

Northwestern University Chicago

Evanston, Illinois, 60611, United States

Location

Silver Cross Hospital

New Lenox, Illinois, 60541, United States

Location

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

Carmel, Indiana, 46290, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Cardiovascular Research Institute of Kansas

Wichita, Kansas, 67226, United States

Location

Medstar Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

CentraCare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Washington University - Barnes-Jewish Hospital Saint Louis

St Louis, Missouri, 63110, United States

Location

St. Patrick Hospital

Missoula, Montana, 59802, United States

Location

Dartmouth-Hitchcock Medical Center, Hanover

Lebanon, New Hampshire, 03756, United States

Location

Atlantic Health System Morristown

Morristown, New Jersey, 07960, United States

Location

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

University at Buffalo - Kaleida Health

Buffalo, New York, 14203, United States

Location

Cornell Medical Center

New York, New York, 10021, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Montefiore Medical Center

New York, New York, 10458, United States

Location

Carolinas Health System

Charlotte, North Carolina, 28203, United States

Location

Novant Health and Heart Vascular Institute

Charlotte, North Carolina, 28204, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oklahoma Cardiovascular Research Group Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Oklahoma Heart Institute

Tulsa, Oklahoma, 74104, United States

Location

Kaiser Portland

Clackamas, Oregon, 97015, United States

Location

Providence Heart & Vascular Institute Portland

Portland, Oregon, 97225, United States

Location

Pinnacle Health Harrisburg

Harrisburg, Pennsylvania, 17101, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Methodist Le Bonheur Healthcare

Germantown, Tennessee, 38138, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

Saint Thomas Health

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor Heart and Vascular Hospital

Dallas, Texas, 75226, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

HCA Houston Healthcare Medical Center

Houston, Texas, 77004, United States

Location

University of Texas Memorial Hermann

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

University of Washington Seattle

Seattle, Washington, 98195, United States

Location

St. Andrews War Memorial Hospital

Spring Hill, Queensland, 4000, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Royal Melbourne Hospital

Parkville, 3050, Australia

Location

St. Paul's Hospital System

Vancouver, British Columbia, V6E 1M7, Canada

Location

Hamilton Health Services

Hamilton, Ontario, L8L 2X2, Canada

Location

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

Québec, Quebec, G1V 4G5, Canada

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

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

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: July 22, 2025
• Study Completion (Estimated): December 1, 2034
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

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