PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
Purpose
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.
Conditions
- Aortic Stenosis, Calcific
- Aortic Valve Stenosis
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TAVR |
Transcatheter Aortic Valve Replacement (TAVR) |
|
|
No Intervention CS |
Clinical Surveillance (CS) |
|
Recruiting Locations
Heart Center LLC, Huntsville
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Cedars-Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Eisenhower Desert Cardiology Center
Rancho Mirage, California 92270
Rancho Mirage, California 92270
Bay Area Structural Heart at Sutter Health
San Francisco, California 94109
San Francisco, California 94109
University of California San Francisco
San Francisco, California 94143
San Francisco, California 94143
Santa Barbara Cottage Hospital
Santa Barbara, California 93105
Santa Barbara, California 93105
Stanford Univeristy
Stanford, California 94305
Stanford, California 94305
UC Health Medical Center of the Rockies
Loveland, Colorado 80538
Loveland, Colorado 80538
Yale Universtiy
New Haven, Connecticut 06510
New Haven, Connecticut 06510
Baptist Health Research Center
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Sarasota Memorial Health Care System
Sarasota, Florida 34239
Sarasota, Florida 34239
Emory University Atlanta
Atlanta, Georgia 30308
Atlanta, Georgia 30308
Piedmont Heart Institute
Atlanta, Georgia 30309
Atlanta, Georgia 30309
Saint Alphonsus
Boise, Idaho 83704
Boise, Idaho 83704
Rush University Medical Center
Chicago, Illinois 60612
Chicago, Illinois 60612
Alexian Brothers Hospital
Lisle, Illinois 60532
Lisle, Illinois 60532
Ascension Via Christi St. Francis
Wichita, Kansas 67226
Wichita, Kansas 67226
Louisiana State University
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Massachusetts General Hospital Boston
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Minneapolis Heart Institue, St. Paul's
Minneapolis, Minnesota 55102
Minneapolis, Minnesota 55102
CentraCare Heart and Vascular Center
Saint Cloud, Minnesota 56303
Saint Cloud, Minnesota 56303
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri 64111
Kansas City, Missouri 64111
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
Atlantic Health System Hospital Corp - Morristown Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Jersey Shore University Medical Center
Neptune City, New Jersey 07753
Neptune City, New Jersey 07753
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey 08901
New Brunswick, New Jersey 08901
The Valley Hospital
Ridgewood, New Jersey 07450
Ridgewood, New Jersey 07450
University of Buffalo Kaleida Health
Buffalo, New York 14203
Buffalo, New York 14203
NYU Langone Hospital - Long Island
Mineola, New York 11501
Mineola, New York 11501
Rochester General Hospital
Rochester, New York 14621
Rochester, New York 14621
St. Francis Hospital
Roslyn, New York 11576
Roslyn, New York 11576
Montefiore Medical Center
The Bronx, New York 10467
The Bronx, New York 10467
Moses Cone Memorial Hospital
Greensboro, North Carolina 27401
Greensboro, North Carolina 27401
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
Tulsa, Oklahoma 74104
Legacy Emanuel Medical Center
Portland, Oregon 97227
Portland, Oregon 97227
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Baptist Memorial Hospital Memphis
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Methodist Le Bonheur Healthcare
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Parkwest Medical Center
Knoxville, Tennessee 37923
Knoxville, Tennessee 37923
Saint Thomas Health
Nashville, Tennessee 37205
Nashville, Tennessee 37205
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Ascension Texas Cardiovascular
Austin, Texas 78705
Austin, Texas 78705
UT Southwestern Medical Center
Dallas, Texas 75235
Dallas, Texas 75235
HCA Houston Healthcare Medical Center
Houston, Texas 77004
Houston, Texas 77004
The University of Texas Health Science Center
Houston, Texas 77030
Houston, Texas 77030
The Heart Hospital Baylor Plano
Plano, Texas 75093
Plano, Texas 75093
Kaiser Mid Atlantic
McLean, Virginia 22102
McLean, Virginia 22102
Sentara Norfolk General Hospital
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Swedish Medical Center
Seattle, Washington 98112
Seattle, Washington 98112
More Details
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
Detailed Description
This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.