Active, not recruitingNo phase
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
Key facts
- Who runs it
- Edwards Lifesciences
- Where
- Albany, Atlanta, Baltimore, Boston, Buffalo, Burlingame, Charleston, Charlotte, Charlottesville, Chicago, Cincinnati, Clackamas, Cleveland, Columbus, Dallas, Detroit, Evanston, Everett, Falls Church, Gainesville, Harrisburg, Houston, Hyannis, Iowa City, Kansas City, Lebanon, Lisle, Los Angeles, Loveland, Milwaukee, Mineola, Minneapolis, Missoula, Morristown, Murray, Nashville, New Haven, New Orleans, New York, Newark, Newport Beach, Norfolk, Pasadena, Phoenix, Piscataway, Pittsburgh, Portland, Raleigh, Roanoke, Rochester, Sacramento, Saint Cloud, San Francisco, Seattle, Spokane, Springfield, Stanford, Stony Brook, The Bronx, Washington D.C., West Des Moines, Wichita, Wynnewood, and York, United StatesSee the 74 sitesAlso in 1 other country, 3 sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 901 people enrolled
- Started
- 12 Jul 2017
- Expected to end
- Mar 2032
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- Record updated
- 13 May 2024
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 36 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patient has any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication
- Evidence of an acute myocardial infarction ≤ 30 days before randomization
- Inability to tolerate or condition precluding treatment with anti-thrombotic therapy
- Severe lung disease or currently on home oxygen
- 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
- 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
- Cardiac imaging evidence of intracardiac mass, thrombus or vegetation
- Stroke or transient ischemic attack within 90 days of randomization
- Renal insufficiency and/or renal replacement therapy
- 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 is symptomatic
- 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
- 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
- Hypertrophic cardiomyopathy with obstruction
- Active bacterial endocarditis within 180 days of randomization
- Patient refuses blood products
- BMI >50 kg/m2
- Estimated life expectancy <24 months
Where in United States
Also in 1 other country, 3 sites
- Albany Medical CollegeAlbany, United StatesNo longer taking part
- Emory UniversityAtlanta, United StatesNo longer taking part
- Piedmont Heart InstituteAtlanta, United StatesNo longer taking part
- University of Maryland Medical CenterBaltimore, United StatesNo longer taking part
- Brigham and Women's HospitalBoston, United StatesNo longer taking part
- University at Buffalo/Kaleida HealthBuffalo, United StatesNo longer taking part
- Mills Peninsula Health ServicesBurlingame, United StatesNo longer taking part
- CAMC Clinical Trials CenterCharleston, United StatesNo longer taking part
- Carolina's Health SystemCharlotte, United StatesNo longer taking part
- University of VirginiaCharlottesville, United StatesNo longer taking part
- Northwestern UniversityChicago, United StatesNo longer taking part
- Rush University Medical Center ChicagoChicago, United StatesNo longer taking part
- The Christ Hospital- CincinnatiCincinnati, United StatesNo longer taking part
- Kaiser PortlandClackamas, United StatesNo longer taking part
- Cleveland Clinic FoundationCleveland, United StatesNo longer taking part
- Mount Carmel Health SystemColumbus, United StatesNo longer taking part
- The Ohio Health Research InstituteColumbus, United StatesNo longer taking part
- Texas Health Physician GroupDallas, United StatesNo longer taking part
- The Heart Hospital Baylor PlanoDallas, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- NorthShore University HealthSystem Research InstitutionEvanston, United StatesNo longer taking part
- Providence EverettEverett, United StatesNo longer taking part
- Inova Heart and Vascular Institute (Fairfax Inova)Falls Church, United StatesNo longer taking part
- The Cardiac & Vascular Institute Research FoundationGainesville, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Pinnacle HealthHarrisburg, United StatesNo longer taking part
- University of Texas Health Science Center at HoustonHouston, United StatesNo longer taking part
- Cape Cod HospitalHyannis, United StatesNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
- Saint Luke's Hospital of Kansas City Mid AmericaKansas City, United StatesNo longer taking part
- Mary Hitchcock Memorial HospitalLebanon, United StatesNo longer taking part
- Alexian Brothers Hospital NetworkLisle, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesNo longer taking part
- UC Health Northern Colorado (Medical Center of the Rockies)Loveland, United StatesNo longer taking part
- Medical College of WisconsinMilwaukee, United StatesNo longer taking part
- NYU Langone Hosptial - Long IslandMineola, United StatesNo longer taking part
- Minneapolis Heart InstituteMinneapolis, United StatesNo longer taking part
- University of Minnesota Medical CenterMinneapolis, United StatesNo longer taking part
- St. Patrick HospitalMissoula, United StatesNo longer taking part
- Atlantic Health System Hospital Corp - Morristown Medical CenterMorristown, United StatesNo longer taking part
- Intermountain Medical Center Salt Lake CityMurray, United StatesNo longer taking part
- Vanderbilt University Medical CenterNashville, United StatesNo longer taking part
- Yale UniversityNew Haven, United StatesNo longer taking part
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- Columbia University Medical Center/New York-Presbyterian HospitalNew York, United StatesNo longer taking part
- Cornell UniversityNew York, United StatesNo longer taking part
- New York University Langone Medical CenterNew York, United StatesNo longer taking part
- Newark Beth Israel Medical CenterNewark, United StatesNo longer taking part
- Hoag Memorial Hospital PresbyterianNewport Beach, United StatesNo longer taking part
- Sentara Cardiovascular Research InstituteNorfolk, United StatesNo longer taking part
- Huntington HospitalPasadena, United StatesNo longer taking part
- Banner University Medical CenterPhoenix, United StatesNo longer taking part
- Rutgers - Robert Wood Johnson Medical SchoolPiscataway, United StatesNo longer taking part
- Allegheny-Singer Research InstitutePittsburgh, United StatesNo longer taking part
- Maine Medical CenterPortland, United StatesNo longer taking part
- NC Heart and Vascular (Rex Hospital)Raleigh, United StatesNo longer taking part
- Carilion Medical CenterRoanoke, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- Rochester General HospitalRochester, United StatesNo longer taking part
- UC Davis Medical CenterSacramento, United StatesNo longer taking part
- CentraCare HeartSaint Cloud, United StatesNo longer taking part
- Kaiser San Francisco Medical CenterSan Francisco, United StatesNo longer taking part
- Swedish Medical CenterSeattle, United StatesNo longer taking part
- University of WashingtonSeattle, United StatesNo longer taking part
- Sacred Heart Medical CenterSpokane, United StatesNo longer taking part
- Prairie Education And Research CooperativeSpringfield, United StatesNo longer taking part
- Stanford Hospital and Clinics Palo AltoStanford, United StatesNo longer taking part
- Stony Brook University Medical CenterStony Brook, United StatesNo longer taking part
- Montefiore Medical CenterThe Bronx, United StatesNo longer taking part
- Washington Hospital Center DCWashington D.C., United StatesNo longer taking part
- Iowa Heart CenterWest Des Moines, United StatesNo longer taking part
- Cardiovascular Research Institute of KansasWichita, United StatesNo longer taking part
- Lankenau Medical CenterWynnewood, United StatesNo longer taking part
- York HospitalYork, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- TAVRTreatment being tested
Transcatheter aortic valve replacement (TAVR)
Treatment: Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- CSNo study treatment, for comparison
Clinical surveillance (CS)
Results explained
Papers that name this trial, each explained in plain words.
- Prevalence and Consequences of Guideline-Directed Indications for Aortic Valve Replacement in the EARLY TAVR Trial.Published 2026
- Age and Procedural Timing for Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial.Published 2026
- Outcomes of Early vs Delayed Aortic Valve Replacement: Analysis of the EARLY TAVR Valve Implant Population.Published 2025
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
- Publications
- Prevalence and Consequences of Guideline-Directed Indications for Aortic Valve Replacement in the EARLY TAVR Trial.JACC. Cardiovascular interventions, 2026
- Treadmill Stress Test in Patients With Asymptomatic Severe Aortic Stenosis: A Prespecified Registry-Based Follow-Up of the EARLY TAVR Randomized Clinical Trial.JAMA cardiology, 2026
- Age and Procedural Timing for Asymptomatic Severe Aortic Stenosis: Analysis From the EARLY TAVR Trial.Circulation. Cardiovascular interventions, 2026
- Outcomes of Early vs Delayed Aortic Valve Replacement: Analysis of the EARLY TAVR Valve Implant Population.JACC. Cardiovascular interventions, 2025
- Record updated
- 13 May 2024