PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR
- Conditions
- Aortic Valve StenosisAortic Stenosis, Calcific
- Interventions
- Device: SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA
- Registration Number
- NCT04889872
- Lead Sponsor
- Edwards Lifesciences
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2250
- 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.
Key
- Native aortic annulus size unsuitable for the THV
- Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system
- Aortic valve is unicuspid or non-calcified
- Bicuspid aortic valve with an aneurysmal ascending aorta > 4.5 cm or severe raphe/leaflet calcification
- Pre-existing mechanical or bioprosthetic aortic valve
- Severe aortic regurgitation
- Prior balloon aortic valvuloplasty to treat severe AS
- LVEF < 20%
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post-TAVR
- Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
- Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Aortic Valve Replacement (TAVR)
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint 2 years Non-hierarchical composite of death, and heart failure hospitalization or event
Primary Safety Endpoint 30 days Non-hierarchical composite of death, stroke, life threatening or fatal bleeding, acute kidney injury stage 4, hospitalization due to device- or procedure-related complication, and valve dysfunction requiring reintervention
- Secondary Outcome Measures
Name Time Method Unplanned cardiovascular hospitalization 2 years The number of patients that had this event
KCCQ overall score 2 years Change from baseline in KCCQ. The KCCQ is a 23-item self-administered questionnaire developed to independently measure the patient's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ) 2 years The number of patients that met all these criteria
Death, stroke, or unplanned cardiovascular hospitalization 2 years The number of patients that had this event
Left ventricle (LV) mass index 2 years Echocardiographic measurement of the size of the left ventricle
Diastolic dysfunction ≥ Grade 2 2 years Echocardiographic measurement of the stiffness of the left ventricle.
Stroke volume index 2 years Echocardiographic measurement of the volume of blood pumped out of the left ventricle during contraction.
Reduction in LVEF ≥ 5% from baseline AND LVEF < 60% 2 years The number of patients that meet these criteria
N-Terminal Pro B-type Natriuretic Peptide (NT-ProBNP) 2 years NT-ProBNP is a hormone that measures heart failure. Levels goes up when heart failure develops or gets worse, and levels goes down when heart failure is stable.
New onset atrial fibrillation 2 years The number of patients that develop this condition
Trial Locations
- Locations (80)
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
Ascension Via Christi St. Francis
🇺🇸Wichita, Kansas, United States
Louisiana State University
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinical Foundation
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital Boston
🇺🇸Boston, Massachusetts, United States
Minneapolis Heart Institue, St. Paul's
🇺🇸Minneapolis, Minnesota, United States
CentraCare Heart and Vascular Center
🇺🇸Saint Cloud, Minnesota, United States
Saint Luke's Hospital of Kansas City Mid America
🇺🇸Kansas City, Missouri, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Mary Hitchcock Memorial Hospital
🇺🇸Lebanon, New Hampshire, United States
Atlantic Health System Hospital Corp - Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
University of Buffalo Kaleida Health
🇺🇸Buffalo, New York, United States
NYU Langone Hospital - Long Island
🇺🇸Mineola, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Irving Medical Center/NYPH
🇺🇸New York, New York, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
Moses Cone Memorial Hospital
🇺🇸Greensboro, North Carolina, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Mount Carmel Health System
🇺🇸Columbus, Ohio, United States
Oklahoma Heart Institute
🇺🇸Tulsa, Oklahoma, United States
Kaiser Permanente Northwest
🇺🇸Clackamas, Oregon, United States
Providence Heart & Vascular Institute Portland
🇺🇸Portland, Oregon, United States
Legacy Emanuel Medical Center
🇺🇸Portland, Oregon, United States
Allegheny Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Presbyterian Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
Pinnacle Health Harrisburg
🇺🇸Wormleysburg, Pennsylvania, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Baptist Memorial Hospital Memphis
🇺🇸Germantown, Tennessee, United States
Methodist Le Bonheur Healthcare
🇺🇸Germantown, Tennessee, United States
Parkwest Medical Center
🇺🇸Knoxville, Tennessee, United States
Saint Thomas Health
🇺🇸Nashville, Tennessee, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Ascension Texas Cardiovascular
🇺🇸Austin, Texas, United States
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
HCA Houston Healthcare Medical Center
🇺🇸Houston, Texas, United States
The University of Texas Health Science Center
🇺🇸Houston, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Methodist Hospital of San Antonio
🇺🇸San Antonio, Texas, United States
Kaiser Mid Atlantic
🇺🇸McLean, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Flinders Medical Centre
🇦🇺Bedford Park, South Australia, Australia
Monash Health
🇦🇺Clayton, Victoria, Australia
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Hamiton Health Services
🇨🇦Hamilton, Onterio, Canada
Kokura Memorial Hospital
🇯🇵Fukuoka, Kyushu, Japan
Sendai Kousei Hospital
🇯🇵Sendai, Miyagi, Japan
Sakakibara Heart Institute
🇯🇵Fuchu, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku, Tokyo, Japan
AMC Amsterdam
🇳🇱Amsterdam, North Holland, Netherlands
Leiden Universitair Medisch Centrum
🇳🇱Leiden, South Holland, Netherlands
Erasmus Rotterdam
🇳🇱Rotterdam, South Holland, Netherlands
Hôpitaux Universitaire de Genève
🇨🇭Geneva, Switzerland
Universitätsspital Zürich
🇨🇭Zürich, Switzerland