EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
a study on Heart Disease Aortic Stenosis
Summary
- Eligibility
- for people ages 65 years and up (full criteria)
- Location
- at UC Davis
- Dates
- study startedcompletion around
Description
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.
Official Title
Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Details
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.
Keywords
Heart Diseases, Aortic Stenosis, Severe, Aortic valve, Asymptomatic, Transcatheter aortic valve replacement, Aortic Valve Stenosis, Pathologic Constriction, Edwards SAPIEN 3 / SAPIEN 3 Ultra THV, TAVR
Eligibility
You can join if…
Open to people ages 65 years and up
- 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.
You CAN'T join if...
- 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
Locations
- UC Davis Medical Center
Sacramento California 95817 United States - Kaiser San Francisco Medical Center
San Francisco California 94115 United States - Cedars-Sinai Medical Center
Los Angeles California 90048 United States - Hoag Memorial Hospital Presbyterian
Newport Beach California 92663 United States - Mills Peninsula Health Services
Burlingame California 94010 United States - Huntington Hospital
Pasadena California 91105 United States - Stanford Hospital and Clinics Palo Alto
Stanford California 94305 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Edwards Lifesciences
- ID
- NCT03042104
- Study Type
- Interventional
- Participants
- About 901 people participating
- Last Updated