RECRUITINGINTERVENTIONAL
PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement
About This Trial
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.
Who May Be Eligible (Plain English)
Key Who May Qualify:
1. 65 years of age or older at time of randomization
2. Moderate aortic stenosis
3. Subject has symptoms or evidence of cardiac damage/dysfunction
4. The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written willing to sign a consent form.
Key Who Should NOT Join This Trial:
1. Native aortic annulus size unsuitable for the THV
2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
3. Aortic valve is unicuspid or non-calcified
4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification
5. Pre-existing mechanical or bioprosthetic aortic valve
6. Severe aortic regurgitation
7. Prior balloon aortic valvuloplasty to treat severe AS
8. LVEF \< 20%
9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Key Inclusion Criteria:
1. 65 years of age or older at time of randomization
2. Moderate aortic stenosis
3. Subject has symptoms or evidence of cardiac damage/dysfunction
4. 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.
Key Exclusion Criteria:
1. Native aortic annulus size unsuitable for the THV
2. Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
3. Aortic valve is unicuspid or non-calcified
4. Bicuspid aortic valve with an aneurysmal ascending aorta \> 4.5 cm or severe raphe/leaflet calcification
5. Pre-existing mechanical or bioprosthetic aortic valve
6. Severe aortic regurgitation
7. Prior balloon aortic valvuloplasty to treat severe AS
8. LVEF \< 20%
9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
10. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
11. Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Treatments Being Tested
DEVICE
SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve
Locations (20)
Heart Center LLC, Huntsville
Huntsville, Alabama, United States
Tucson Medical Center
Tucson, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Huntington Hospital
Pasadena, California, United States
Eisenhower Desert Cardiology Center
Rancho Mirage, California, United States
Bay Area Structural Heart at Sutter Health
San Francisco, California, United States
Kaiser San Francisco Medical Center
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Stanford Univeristy
Stanford, California, United States
UC Health Medical Center of the Rockies
Loveland, Colorado, United States
Yale Universtiy
New Haven, Connecticut, United States
The Cardiac & Vascular Institute Research Foundation
Gainesville, Florida, United States
Baptist Health Research Center
Jacksonville, Florida, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Emory University Atlanta
Atlanta, Georgia, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Saint Alphonsus
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Alexian Brothers Hospital
Lisle, Illinois, United States