EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Edwards Lifesciences

Status

Active, not recruiting

Conditions

Aortic Stenosis, Severe

Heart Diseases

Treatments

Device: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV

Study type

Interventional

Funder types

Industry

Identifiers

NCT03042104

2016-07

Details and patient eligibility

About

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.

Full 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.

Enrollment

901 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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