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Clinical Trials in Israel / NCT03042104
Active, not recruiting Not applicable

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

NCT03042104 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2017-07-12
Last updated
2024-05-13

Condition(s) studied

Heart DiseasesAortic Stenosis, Severe

Investigational drug(s) / intervention(s)

Edwards SAPIEN 3 / SAPIEN 3 Ultra THV

Edwards SAPIEN 3 / SAPIEN 3 Ultra THV: Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. 65 years of age or older 2. Severe aortic stenosis 3. Patient is asymptomatic 4. LV ejection fraction ≥ 50% 5. Society of Thoracic Surgeons (STS) risk score ≤ 10 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent. Exclusion Criteria: 1. Patient is symptomatic 2. Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication. 3. Native aortic annulus size unsuitable for sizes 20, 23, 26, or 29 mm THV 4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath. 5. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak post TAVR 6. Evidence of an acute myocardial infarction ≤ 30 days before randomization 7. Aortic valve is unicuspid, bicuspid with unfavorable features for TAVR, or is non-calcified 8. Severe aortic regurgitation (\>3+) 9. Severe mitral regurgitation (\>3+) or ≥ moderate mitral stenosis 10. Pre-existing mechanical or bioprosthetic valve in any position 11. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days of randomization 12. Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states 13. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of randomization 14. Hypertrophic cardiomyopathy with obstruction 15. Cardiac imaging evidence of intracardiac mass, thrombus or vegetation 16. Inability to tolerate or condition precluding treatment with anti-thrombotic therapy 17. Stroke or transient ischemic attack within 90 days of randomization 18. Renal insufficiency and/or renal replacement therapy 19. Active bacterial endocarditis within 180 days of randomization 20. Severe lung disease or currently on home oxygen 21. Severe pulmonary hypertension 22. History of cirrhosis or any active liver disease 23. Significant frailty as determined by the Heart Team 24. Significant abdominal or thoracic aortic disease that would preclude safe passage of the delivery system 25. Patient refuses blood products 26. BMI \>50 kg/m2 27. Estimated life expectancy \<24 months 28. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with pre-medication 29. Currently participating in an investigational drug or another device study. 30. Active SARS-CoV-2 infection (Coronavirus-19 \[COVID-19\]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments

Primary outcome measure(s)

Trial sites (77)

FacilityCityRegionStatus
Banner University Medical Center Phoenix Arizona
Mills Peninsula Health Services Burlingame California
Cedars-Sinai Medical Center Los Angeles California
Hoag Memorial Hospital Presbyterian Newport Beach California
Huntington Hospital Pasadena California
UC Davis Medical Center Sacramento California
Kaiser San Francisco Medical Center San Francisco California
Stanford Hospital and Clinics Palo Alto Stanford California
UC Health Northern Colorado (Medical Center of the Rockies) Loveland Colorado
Yale University New Haven Connecticut
Washington Hospital Center DC Washington D.C. District of Columbia
The Cardiac & Vascular Institute Research Foundation Gainesville Florida
University of Florida Gainesville Florida
Piedmont Heart Institute Atlanta Georgia
Emory University Atlanta Georgia
Northwestern University Chicago Illinois
Rush University Medical Center Chicago Chicago Illinois
NorthShore University HealthSystem Research Institution Evanston Illinois
Alexian Brothers Hospital Network Lisle Illinois
Prairie Education and Research Cooperative Springfield Illinois
University of Iowa Hospitals and Clinics Iowa City Iowa
Iowa Heart Center West Des Moines Iowa
Cardiovascular Research Institute of Kansas Wichita Kansas
Ochsner Clinic Foundation New Orleans Louisiana
Maine Medical Center Portland Maine
University of Maryland Medical Center Baltimore Maryland
Brigham and Women's Hospital Boston Massachusetts
Cape Cod Hospital Hyannis Massachusetts
Henry Ford Hospital Detroit Michigan
Minneapolis Heart Institute Minneapolis Minnesota
University of Minnesota Medical Center Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
CentraCare Heart Saint Cloud Minnesota
Saint Luke's Hospital of Kansas City Mid America Kansas City Missouri
St. Patrick Hospital Missoula Montana
Mary Hitchcock Memorial Hospital Lebanon New Hampshire
Atlantic Health System Hospital Corp - Morristown Medical Center Morristown New Jersey
Newark Beth Israel Medical Center Newark New Jersey
Rutgers Robert Wood Johnson Medical School Piscataway New Jersey
Albany Medical College Albany New York

+ 37 more sites — see the full list on the official registry below.

More Edwards Lifesciences trials in Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03042104 on ClinicalTrials.gov ↗ ← All trials in Israel