Safety and Effectiveness of Balloon-Expandable Bioprosthetic SAPIEN X4 Transcatheter Heart Valve in Failing Aortic Bioprosthetic Valves
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The objective of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects who are at high or greater risk with a failing aortic bioprosthetic valve.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Bay Area Structural Heart at Sutter Health
RECRUITING
San Francisco
Kaiser San Francisco
RECRUITING
San Francisco
Stanford University Medical Center
RECRUITING
Stanford
Colorado
UC Health Medical Center of the Rockies
RECRUITING
Loveland
Florida
Naples Community Hospital Healthcare System
RECRUITING
Naples
Georgia
Emory University Atlanta
RECRUITING
Atlanta
Piedmont Heart Institute
RECRUITING
Atlanta
Illinois
Northwestern University Chicago
RECRUITING
Evanston
Alexian Brothers Hospital Network
RECRUITING
Lisle
Kansas
Cardiovascular Research Institute of Kansas
RECRUITING
Wichita
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Maryland
MedStar Union Memorial Hospital
RECRUITING
Baltimore
Michigan
Henry Ford Hospital Detroit
RECRUITING
Detroit
Minnesota
Mayo Clinic
RECRUITING
Rochester
North Carolina
Carolinas Health System
RECRUITING
Charlotte
Novant Health and Vascular Institute
RECRUITING
Charlotte
New Jersey
Atlantic Health System Morristown
RECRUITING
Morristown
Robert Wood Johnson University Hospital
RECRUITING
New Brunswick
The Valley Hospital
RECRUITING
Ridgewood
New York
University of Buffalo
RECRUITING
Buffalo
Columbia University Medical Center / NYPH
RECRUITING
New York
Cornelll University New York
RECRUITING
New York
Rochester General Hospital
RECRUITING
Rochester
Ohio
The Christ Hospital
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Oklahoma
Oklahoma Heart Institute
RECRUITING
Tulsa
Pennsylvania
Allegheny General Hospital
RECRUITING
Pittsburgh
Tennessee
Saint Thomas Health
RECRUITING
Nashville
Texas
University of Texas Memorial Hermann
RECRUITING
Houston
The Heart Hospital Baylor Plano
RECRUITING
Plano
Washington
University of Washington Seattle
WITHDRAWN
Seattle
Other Locations
Canada
Hamilton Health Sciences
RECRUITING
Hamilton
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Universite Laval
RECRUITING
Québec
St. Paul's Hospital Vancouver
RECRUITING
Vancouver
Contact Information
Primary
Edwards THV Clinical Affairs
THV_CT.gov@Edwards.com
949-250-2500
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2034-02
Participants
Target number of participants: 200
Treatments
Experimental: Transcatheter Aortic Valve Replacement (TAVR) - Surgical Valve
TAVR implant in subjects with a failing aortic surgical valve.
Experimental: Transcatheter Aortic Valve Replacement (TAVR) - THV
TAVR implant in subjects with a failing aortic transcatheter heart valve (THV).
Authors
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences