A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve Implantation in Patients With a Failing Aortic Bioprosthetic Valve
Status: Recruiting
Location: See all (51) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Failing surgical or transcatheter bioprosthetic valve in the aortic position demonstrating ≥ moderate stenosis and/or ≥ moderate insufficiency.
• Bioprosthetic valve with a true internal diameter (True ID) of 18.5 mm to 28.5 mm.
• NYHA Functional Class ≥ II.
• Heart Team agrees the patient is low to intermediate risk.
• Heart Team agrees valve implantation will likely benefit the patient.
• The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Locations
United States
Arizona
Banner University Medical Center
RECRUITING
Phoenix
California
University of California Los Angeles
RECRUITING
Los Angeles
Sutter Medical Center
RECRUITING
Sacramento
Kaiser Permanente San Francisco
WITHDRAWN
San Francisco
Stanford University Medical Center
RECRUITING
Stanford
Colorado
UC Health Northern Colorado/Medical Center of the Rockies
RECRUITING
Loveland
Connecticut
Hartford Hospital
RECRUITING
Hartford
Florida
JFK Medical Center/ Atlantic Clinical Research Collaborative
WITHDRAWN
Atlantis
University of Florida, Gainesville
WITHDRAWN
Gainesville
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
Northwestern University Hospital
RECRUITING
Chicago
Rush University Medical Center
RECRUITING
Chicago
Northshore University HealthSystem
WITHDRAWN
Evanston
Prairie Education and Research Cooperative
WITHDRAWN
Springfield
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Michigan
Henry Ford Hospital
RECRUITING
Detroit
William Beaumont Hospital
WITHDRAWN
Royal Oak
Minnesota
University of Minnesota Medical Center
WITHDRAWN
Minneapolis
Mayo Clinic
RECRUITING
Rochester
Missouri
Saint Luke's Hospital of Kansas City Mid America
WITHDRAWN
Kansas City
Washington University/ Barnes-Jewish Hospital
RECRUITING
St Louis
North Carolina
Carolina's Health System
WITHDRAWN
Charlotte
NC Heart and Vascular (Rex Hospital)
WITHDRAWN
Raleigh
Nebraska
Nebraska Heart Institute
WITHDRAWN
Lincoln
New Hampshire
Dartmouth-Hitchcock Medical Center
WITHDRAWN
Lebanon
New Jersey
Newark Beth Israel
RECRUITING
Newark
New York
University of Buffalo
WITHDRAWN
Buffalo
Winthrop University Hospital
RECRUITING
Mineola
Columbia University Medical Center/ New York Presbyterian Hospital
RECRUITING
New York
Cornell University
RECRUITING
New York
New York University (NYU) Langone Medical Center
WITHDRAWN
New York
Ohio
The Christ Hospital
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Oklahoma
Oklahoma Cardiovascular Research Group
WITHDRAWN
Oklahoma City
Oregon
Providence Heart & Vascular Institute
RECRUITING
Portland
Pennsylvania
University of Pennsylvania Hospital
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
Lankenau Medical Center
RECRUITING
Wynnewood
Tennessee
Baptist Memorial Hospital
WITHDRAWN
Memphis
Saint Thomas Health Services
WITHDRAWN
Nashville
Texas
Austin Heart, PLLC
WITHDRAWN
Austin
Medical City Dallas Hospital
RECRUITING
Dallas
The Heart Hospital Baylor Plano
RECRUITING
Dallas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
Intermountain Medical Center
RECRUITING
Murray
Virginia
University of Virginia
WITHDRAWN
Charlottesville
Inova Heart and vascular Instritute (Fairfax Inova)
WITHDRAWN
Fairfax
Sentara Cardiovascular Research Institute
RECRUITING
Norfolk
Wisconsin
University of Wisconsin - Madison
WITHDRAWN
Madison
Other Locations
Canada
St. Paul's Hospital, Providence Health Care
RECRUITING
Vancouver
Contact Information
Primary
Edwards THV Clinical Affairs
THV_CT.gov@Edwards.com
(949) 250-2500
Time Frame
Start Date: 2017-01-05
Estimated Completion Date: 2038-04
Participants
Target number of participants: 125
Treatments
Experimental: TAVR - Failing surgical or transcatheter valve
Patients with a failing surgical or transcatheter bioprosthetic valve will undergo transcatheter aortic valve replacement (TAVR).
Authors
S. Chris Malaisrie, Richard Shemin
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences