EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
- Conditions
- Aortic Stenosis, SevereHeart Diseases
- Interventions
- Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- Registration Number
- NCT03042104
- Lead Sponsor
- Edwards Lifesciences
- Brief Summary
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
- Detailed Description
This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 901
- 65 years of age or older
- Severe aortic stenosis
- Patient is asymptomatic
- LV ejection fraction ≥ 50%
- Society of Thoracic Surgeons (STS) risk score ≤ 10
- The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- Patient is symptomatic
- Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication.
- Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV
- Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath.
- Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR
- Evidence of an acute myocardial infarction ≤ 30 days before randomization
- Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified
- Severe aortic regurgitation (>3+)
- Severe mitral regurgitation (>3+) or ≥ moderate mitral stenosis
- Pre-existing mechanical or bioprosthetic valve in any position
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization
- Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization
- Hypertrophic cardiomyopathy with obstruction
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Inability to tolerate or condition precluding treatment with anti-thrombotic therapy
- Stroke or transient ischemic attack within 90 days of randomization
- Renal insufficiency and/or renal replacement therapy
- Active bacterial endocarditis within 180 days of randomization
- Severe lung disease or currently on home oxygen
- Severe pulmonary hypertension
- History of cirrhosis or any active liver disease
- Significant frailty as determined by the Heart Team
- Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system
- Patient refuses blood products
- BMI >50 kg/m2
- Estimated life expectancy <24 months
- Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication
- Currently participating in an investigational drug or another device study.
- Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR Edwards SAPIEN 3 / SAPIEN 3 Ultra THV Transcatheter aortic valve replacement (TAVR)
- Primary Outcome Measures
Name Time Method All-cause death, all stroke, and unplanned cardiovascular hospitalization When all patients have reached 2-year follow-up The number of patients that have any of these conditions
- Secondary Outcome Measures
Name Time Method Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥75 and 3) KCCQ decrease ≤10 points 2 years The number of patients that meet all of these criteria
Left Ventricular Health 2 years Echocardiographic measurements that will assess the health of the left ventricle
Change in Left Ventricular Ejection Fraction (LVEF) 2 years The average change in LVEF from baseline
New onset atrial fibrillation When all patients have reached 2-year follow-up The number of patients that develop this condition
Death or disabling stroke When all patients have reached 2-year follow-up The number of patients that have any of these conditions
Trial Locations
- Locations (77)
York Hospital
🇺🇸York, Pennsylvania, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
The Christ Hospital, Cincinnati
🇺🇸Cincinnati, Ohio, United States
Kaiser San Francisco Medical Center
🇺🇸San Francisco, California, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Allegheny - Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Pinnacle Health
🇺🇸Harrisburg, Pennsylvania, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Heart Hospital Baylor Plano
🇺🇸Dallas, Texas, United States
Texas Health Physician Group
🇺🇸Dallas, Texas, United States
Intermountain Medical Center Salt Lake City
🇺🇸Murray, Utah, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Inova Heart and Vascular Institute (Fairfax Inova)
🇺🇸Falls Church, Virginia, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
CAMC Clinical Trials Center
🇺🇸Charleston, West Virginia, United States
Carilion Medical Center
🇺🇸Roanoke, Virginia, United States
Providence Everett
🇺🇸Everett, Washington, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
University at Buffalo - Kaleida Health
🇺🇸Buffalo, New York, United States
NYU Langone Hosptial - Long Island
🇺🇸Mineola, New York, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
Columbia University Medical Center/ New York Presbyterian Hospital
🇺🇸New York, New York, United States
NC Heart and Vascular (Rex Hospital)
🇺🇸Raleigh, North Carolina, United States
University of Washington
🇺🇸Seattle, Washington, United States
Mills Peninsula Health Services
🇺🇸Burlingame, California, United States
Huntington Hospital
🇺🇸Pasadena, California, United States
UC Health Northern Colorado (Medical Center of the Rockies)
🇺🇸Loveland, Colorado, United States
Stanford Hospital and Clinics Palo Alto
🇺🇸Stanford, California, United States
Washington Hospital Center DC
🇺🇸Washington, District of Columbia, United States
Rush University Medical Center Chicago
🇺🇸Chicago, Illinois, United States
NorthShore University HealthSystem Research Institution
🇺🇸Evanston, Illinois, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Alexian Brothers Hospital Network
🇺🇸Lisle, Illinois, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Cape Cod Hospital
🇺🇸Hyannis, Massachusetts, United States
CentraCare Heart
🇺🇸Saint Cloud, Minnesota, United States
Atlantic Health System Hospital Corp - Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Rutgers Robert Wood Johnson Medical School
🇺🇸Piscataway, New Jersey, United States
Albany Medical College
🇺🇸Albany, New York, United States
The Ohio Health Research Institute
🇺🇸Columbus, Ohio, United States
Kaiser Portland
🇺🇸Clackamas, Oregon, United States
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Sentara Cardiovascular Research Institute
🇺🇸Norfolk, Virginia, United States
Mary Hitchcock Memorial Hospital
🇺🇸Lebanon, New Hampshire, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Cornell University
🇺🇸New York, New York, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Mount Carmel Health System
🇺🇸Columbus, Ohio, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
St. Patrick Hospital
🇺🇸Missoula, Montana, United States
Banner University Medical Center
🇺🇸Phoenix, Arizona, United States
UC Davis Medical Center
🇺🇸Sacramento, California, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Saint Luke's Hospital of Kansas City Mid America
🇺🇸Kansas City, Missouri, United States
The Cardiac & Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Carolina's Health System
🇺🇸Charlotte, North Carolina, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States