EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
NCT ID: NCT03042104
Last Updated: 2024-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
901 participants
INTERVENTIONAL
2017-07-12
2032-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAVR
Transcatheter aortic valve replacement (TAVR)
Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
CS
Clinical surveillance (CS)
No interventions assigned to this group
Interventions
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Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Philippe Généreux, MD
Role: PRINCIPAL_INVESTIGATOR
Gagnon Cardiovascular Institute - Morristown Medical Center, Cardiovascular Research Foundation
Locations
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Banner University Medical Center
Phoenix, Arizona, United States
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
University of Maryland Medical Center
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Cape Cod Hospital
Hyannis, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CentraCare Heart
Saint Cloud, Minnesota, United States
Saint Luke's Hospital of Kansas City Mid America
Kansas City, Missouri, United States
St. Patrick Hospital
Missoula, Montana, United States
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, 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
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
Cornell University
New York, New York, United States
Rochester General Hospital
Rochester, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina's Health System
Charlotte, North Carolina, United States
NC Heart and Vascular (Rex Hospital)
Raleigh, North Carolina, United States
The Christ Hospital, Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Mount Carmel Health System
Columbus, Ohio, United States
The Ohio Health Research Institute
Columbus, Ohio, United States
Kaiser Portland
Clackamas, Oregon, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Allegheny - Singer Research Institute
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Heart Hospital Baylor Plano
Dallas, Texas, United States
Texas Health Physician Group
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Intermountain Medical Center Salt Lake City
Murray, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Heart and Vascular Institute (Fairfax Inova)
Falls Church, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Carilion Medical Center
Roanoke, Virginia, United States
Providence Everett
Everett, Washington, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
CAMC Clinical Trials Center
Charleston, West Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hamilton Health Sciences
Hamilton, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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References
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Lindman BR, Pibarot P, Schwartz A, Cohen DJ, Giustino G, Oldemeyer JB, Strote JA, Babaliaros V, Devireddy CM, Fearon WF, Fischbein MP, Daniels D, Spies C, Chhatriwalla AK, Kavinsky CJ, Shah P, Szerlip M, Dahle T, Stegman B, O'Leary JM, O'Neill WW, Makkar RR, Davidson CJ, Sheth T, DeVries JT, Southard J, Depta JP, Pop A, Leipsic J, Blanke P, Li Y, Hahn RT, Leon MB, Genereux P. Left Ventricular Health and TAVR Timing in Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial. J Am Coll Cardiol. 2025 Sep 7:S0735-1097(25)07642-9. doi: 10.1016/j.jacc.2025.08.071. Online ahead of print.
Lindman BR, Pibarot P, Schwartz A, Oldemeyer JB, Su YR, Goel K, Cohen DJ, Fearon WF, Babaliaros V, Daniels D, Chhatriwalla A, Suradi HS, Shah P, Szerlip M, Mack MJ, Dahle T, O'Neill WW, Davidson CJ, Makkar R, Sheth T, Depta J, DeVries JT, Southard J, Pop A, Sorajja P, Hahn RT, Zhao Y, Leon MB, Genereux P; EARLY TAVR Trial Executive Committee and Study Investigators. Cardiac Biomarkers in Patients With Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial. Circulation. 2025 Jun 3;151(22):1550-1564. doi: 10.1161/CIRCULATIONAHA.125.074425. Epub 2025 Mar 31.
Genereux P, Schwartz A, Oldemeyer JB, Pibarot P, Cohen DJ, Blanke P, Lindman BR, Babaliaros V, Fearon WF, Daniels DV, Chhatriwalla AK, Kavinsky C, Gada H, Shah P, Szerlip M, Dahle T, Goel K, O'Neill W, Sheth T, Davidson CJ, Makkar RR, Prince H, Zhao Y, Hahn RT, Leipsic J, Redfors B, Pocock SJ, Mack M, Leon MB; EARLY TAVR Trial Investigators. Transcatheter Aortic-Valve Replacement for Asymptomatic Severe Aortic Stenosis. N Engl J Med. 2025 Jan 16;392(3):217-227. doi: 10.1056/NEJMoa2405880. Epub 2024 Oct 28.
Genereux P, Schwartz A, Oldemeyer B, Cohen DJ, Redfors B, Prince H, Zhao Y, Lindman BR, Pibarot P, Leon MB. Design and rationale of the evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis: The EARLY TAVR trial. Am Heart J. 2024 Feb;268:94-103. doi: 10.1016/j.ahj.2023.11.019. Epub 2023 Dec 4.
Zelis JM, Tonino PAL, Pijls NHJ, De Bruyne B, Kirkeeide RL, Gould KL, Johnson NP. Coronary Microcirculation in Aortic Stenosis: Pathophysiology, Invasive Assessment, and Future Directions. J Interv Cardiol. 2020 Jul 22;2020:4603169. doi: 10.1155/2020/4603169. eCollection 2020.
Other Identifiers
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2016-07
Identifier Type: -
Identifier Source: org_study_id
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