The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
Status: Recruiting
Location: See all (80) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 65 years of age or older at time of randomization
• Moderate aortic stenosis
• Subject has symptoms or evidence of cardiac damage/dysfunction
• The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Locations
United States
Alabama
Heart Center LLC, Huntsville
RECRUITING
Huntsville
Arizona
Tucson Medical Center
ACTIVE_NOT_RECRUITING
Tucson
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Huntington Hospital
WITHDRAWN
Pasadena
Eisenhower Desert Cardiology Center
RECRUITING
Rancho Mirage
Bay Area Structural Heart at Sutter Health
RECRUITING
San Francisco
Kaiser San Francisco Medical Center
ACTIVE_NOT_RECRUITING
San Francisco
University of California San Francisco
RECRUITING
San Francisco
Santa Barbara Cottage Hospital
RECRUITING
Santa Barbara
Stanford Univeristy
RECRUITING
Stanford
Colorado
UC Health Medical Center of the Rockies
RECRUITING
Loveland
Connecticut
Yale Universtiy
RECRUITING
New Haven
Florida
The Cardiac & Vascular Institute Research Foundation
WITHDRAWN
Gainesville
Baptist Health Research Center
RECRUITING
Jacksonville
Sarasota Memorial Health Care System
RECRUITING
Sarasota
Georgia
Emory University Atlanta
RECRUITING
Atlanta
Piedmont Heart Institute
RECRUITING
Atlanta
Idaho
Saint Alphonsus
RECRUITING
Boise
Illinois
Rush University Medical Center
ACTIVE_NOT_RECRUITING
Chicago
Alexian Brothers Hospital
RECRUITING
Lisle
Kansas
Ascension Via Christi St. Francis
RECRUITING
Wichita
Louisiana
Louisiana State University
RECRUITING
New Orleans
Ochsner Clinical Foundation
ACTIVE_NOT_RECRUITING
New Orleans
Massachusetts
Massachusetts General Hospital Boston
RECRUITING
Boston
Minnesota
Minneapolis Heart Institue, St. Paul's
RECRUITING
Minneapolis
CentraCare Heart and Vascular Center
RECRUITING
Saint Cloud
Missouri
Saint Luke's Hospital of Kansas City Mid America
RECRUITING
Kansas City
Montana
St. Patrick Hospital
ACTIVE_NOT_RECRUITING
Missoula
North Carolina
Moses Cone Memorial Hospital
RECRUITING
Greensboro
New Hampshire
Mary Hitchcock Memorial Hospital
RECRUITING
Lebanon
New Jersey
Atlantic Health System Hospital Corp - Morristown Medical Center
RECRUITING
Morristown
Jersey Shore University Medical Center
RECRUITING
Neptune City
Rutgers Robert Wood Johnson Medical School
RECRUITING
New Brunswick
The Valley Hospital
RECRUITING
Ridgewood
New York
University of Buffalo Kaleida Health
RECRUITING
Buffalo
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Columbia University Irving Medical Center/NYPH
ACTIVE_NOT_RECRUITING
New York
NYU Langone Health
WITHDRAWN
New York
Rochester General Hospital
RECRUITING
Rochester
St. Francis Hospital
RECRUITING
Roslyn
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
The Christ Hospital
ACTIVE_NOT_RECRUITING
Cincinnati
Mount Carmel Health System
ACTIVE_NOT_RECRUITING
Columbus
Oklahoma
Oklahoma Heart Institute
RECRUITING
Tulsa
Oregon
Kaiser Permanente Northwest
ACTIVE_NOT_RECRUITING
Clackamas
Legacy Emanuel Medical Center
RECRUITING
Portland
Providence Heart & Vascular Institute Portland
WITHDRAWN
Portland
Pennsylvania
Allegheny Singer Research Institute
RECRUITING
Pittsburgh
UPMC Presbyterian Shadyside
ACTIVE_NOT_RECRUITING
Pittsburgh
Pinnacle Health Harrisburg
ACTIVE_NOT_RECRUITING
Wormleysburg
Lankenau Medical Center
RECRUITING
Wynnewood
Tennessee
Baptist Memorial Hospital Memphis
RECRUITING
Germantown
Methodist Le Bonheur Healthcare
RECRUITING
Germantown
Parkwest Medical Center
RECRUITING
Knoxville
Saint Thomas Health
RECRUITING
Nashville
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Ascension Texas Cardiovascular
RECRUITING
Austin
UT Southwestern Medical Center
RECRUITING
Dallas
HCA Houston Healthcare Medical Center
RECRUITING
Houston
The University of Texas Health Science Center
RECRUITING
Houston
The Heart Hospital Baylor Plano
RECRUITING
Plano
Methodist Hospital of San Antonio
ACTIVE_NOT_RECRUITING
San Antonio
Virginia
Kaiser Mid Atlantic
RECRUITING
Mclean
Sentara Norfolk General Hospital
RECRUITING
Norfolk
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital
ACTIVE_NOT_RECRUITING
Adelaide
Flinders Medical Centre
ACTIVE_NOT_RECRUITING
Bedford Park
The Prince Charles Hospital
ACTIVE_NOT_RECRUITING
Chermside
Monash Health
ACTIVE_NOT_RECRUITING
Clayton
Canada
Hamiton Health Services
ACTIVE_NOT_RECRUITING
Hamilton
St. Paul's Hospital
ACTIVE_NOT_RECRUITING
Vancouver
Japan
Sakakibara Heart Institute
ACTIVE_NOT_RECRUITING
Fuchū
Kokura Memorial Hospital
ACTIVE_NOT_RECRUITING
Fukuoka
Sendai Kousei Hospital
ACTIVE_NOT_RECRUITING
Sendai
Keio University Hospital
ACTIVE_NOT_RECRUITING
Shinjuku
Netherlands
AMC Amsterdam
ACTIVE_NOT_RECRUITING
Amsterdam
Leiden Universitair Medisch Centrum
ACTIVE_NOT_RECRUITING
Leiden
Erasmus Rotterdam
ACTIVE_NOT_RECRUITING
Rotterdam
Switzerland
Hôpitaux Universitaire de Genève
ACTIVE_NOT_RECRUITING
Geneva
Universitätsspital Zürich
WITHDRAWN
Zurich
Contact Information
Primary
Edwards THV Clinical Affairs
THV_CT.gov@Edwards.com
949-250-2500
Time Frame
Start Date: 2021-10-12
Estimated Completion Date: 2037-06
Participants
Target number of participants: 2250
Treatments
Experimental: TAVR
Transcatheter Aortic Valve Replacement (TAVR)
No_intervention: CS
Clinical Surveillance (CS)
Related Therapeutic Areas
Sponsors
Leads: Edwards Lifesciences