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

NAActive, not recruitingINTERVENTIONAL
Enrollment

915

Participants

Timeline

Start Date

June 20, 2022

Primary Completion Date

July 22, 2025

Study Completion Date

December 31, 2034

Conditions
Aortic Stenosis, Severe
Interventions
DEVICE

SAPIEN X4 THV

Implantation of the SAPIEN X4 valve

Trial Locations (65)

3050

The Royal Melbourne Hospital, Parkville

4000

St. Andrews War Memorial Hospital, Spring Hill

5000

Royal Adelaide Hospital, Adelaide

8011

Christchurch Hospital, Christchurch

10021

Cornell Medical Center, New York

10032

Columbia University Medical Center/NYPH, New York

10458

Montefiore Medical Center, New York

14203

University at Buffalo - Kaleida Health, Buffalo

15212

Allegheny General Hospital, Pittsburgh

17101

Pinnacle Health Harrisburg, Harrisburg

21218

Medstar Union Memorial Hospital, Baltimore

23507

Sentara Norfolk General Hospital, Norfolk

28203

Carolinas Health System, Charlotte

28204

Novant Health and Heart Vascular Institute, Charlotte

30309

Piedmont Heart Institute, Atlanta

30322

Emory University Atlanta, Atlanta

34102

Naples Community Hospital Healthcare System, North Naples

37203

Centennial Medical Center, Nashville

37205

Saint Thomas Health, Nashville

37232

Vanderbilt University Medical Center, Nashville

38138

Methodist Le Bonheur Healthcare, Germantown

44195

The Cleveland Clinic Foundation, Cleveland

45219

The Christ Hospital, Cincinnati

46290

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

48202

Henry Ford Hospital, Detroit

55905

Mayo Clinic Rochester, Rochester

56303

CentraCare Heart and Vascular Center, Saint Cloud

59802

St. Patrick Hospital, Missoula

60007

Alexian Brothers Hospital Network, Elk Grove Village

60201

NorthShore University HealthSystem Research Institute Evanston, Evanston

60541

Silver Cross Hospital, New Lenox

60611

Northwestern University Chicago, Evanston

60612

Rush University Medical Center Chicago, Chicago

63110

Washington University - Barnes-Jewish Hospital Saint Louis, St Louis

64111

Saint Luke's Hospital, Kansas City

66160

University of Kansas Medical Center, Kansas City

67226

Cardiovascular Research Institute of Kansas, Wichita

73120

Oklahoma Cardiovascular Research Group Oklahoma City, Oklahoma City

74104

Oklahoma Heart Institute, Tulsa

75093

The Heart Hospital Baylor Plano, Plano

75226

Baylor Heart and Vascular Hospital, Dallas

75230

Medical City Dallas Hospital, Dallas

77004

HCA Houston Healthcare Medical Center, Houston

77030

University of Texas Memorial Hermann, Houston

80538

UC Health Northern Colorado (Medical Center of the Rockies), Loveland

90027

Kaiser Los Angeles, Los Angeles

90048

Cedars-Sinai Medical Center, Los Angeles

92037

Scripps Memorial Hospital La Jolla, La Jolla

92663

Hoag Memorial Hospital Presbyterian, Newport Beach

94109

Bay Area Structural Heart at Sutter Health, San Francisco

94115

Kaiser San Francisco Medical Center, San Francisco

94305

Stanford University, Stanford

95817

UC Davis Medical Center Sacramento, Sacramento

97015

Kaiser Portland, Clackamas

97225

Providence Heart & Vascular Institute Portland, Portland

98195

University of Washington Seattle, Seattle

06102

Hartford Hospital, Hartford

02115

Brigham and Women's Hospital, Boston

03756

Dartmouth-Hitchcock Medical Center, Hanover, Lebanon

07960

Atlantic Health System Morristown, Morristown

08901

Rutgers Robert Wood Johnson Medical School, New Brunswick

07450

The Valley Hospital, Ridgewood

V6E 1M7

St. Paul's Hospital System, Vancouver

L8L 2X2

Hamilton Health Services, Hamilton

G1V 4G5

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

Sponsors
All Listed Sponsors
lead

Edwards Lifesciences

INDUSTRY