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

Running, not enrolling · Not applicable

Conditions studied: Heart Diseases, Aortic Stenosis, Severe

In brief

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.

Key facts

Study ID

NCT03042104

Run by

Edwards Lifesciences

People needed

901

Starts

2017-07-12

Expected to finish

2032-03-01

Last updated by the study team

2024-05-13

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Mills Peninsula Health Services — Burlingame, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Huntington Hospital — Pasadena, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Kaiser San Francisco Medical Center — San Francisco, California, United States
• Stanford Hospital and Clinics Palo Alto — Stanford, California, United States
• UC Health Northern Colorado (Medical Center of the Rockies) — Loveland, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Washington Hospital Center DC — Washington D.C., District of Columbia, United States
• The Cardiac & Vascular Institute Research Foundation — Gainesville, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Piedmont Heart Institute — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center Chicago — Chicago, Illinois, United States
• NorthShore University HealthSystem Research Institution — Evanston, Illinois, United States
• Alexian Brothers Hospital Network — Lisle, Illinois, United States
• Prairie Education and Research Cooperative — Springfield, Illinois, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Cardiovascular Research Institute of Kansas — Wichita, Kansas, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Banner University Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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