Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
1103 participants
INTERVENTIONAL
2021-04-02
2027-12-31
Brief Summary
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Additionally, a stress echocardiography sub-study will be conducted as part of the SMART Trial at select sites. The purpose of the sub-study is to evaluate performance of SE versus BE TAVR in subjects with a small aortic annulus and symptomatic severe native aortic stenosis after undergoing exercise stress echocardiographic testing.
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Detailed Description
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The primary objectives of the trial are to demonstrate clinical non-inferiority and hemodynamic superiority of the Evolut PRO/PRO+/FX System when compared to subjects treated with the SAPIEN 3/3 Ultra System at 12 months post-procedure.
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE Transcatheter Aortic Valve (TAV) or an Edwards BE Transcatheter Heart Valve (THV). Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
Product Names:
* Medtronic Evolut PRO and Evolut PRO+ TAV Systems, Evolut FX System (Commercially available in the United States and may be used upon commercial availability in Canada.)
* Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems
The exercise stress echocardiographic testing at select SMART Trial sites seeks to evaluate the performance of the prosthetic aortic valve during exercise. The stress echocardiogram assessment will be conducted as part of the 12-month visit for participating subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medtronic Self-Expanding TAV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
Edwards Balloon-Expandable THV
Subjects will be randomized on a 1:1 basis to receive TAVR with either a Medtronic SE TAV or an Edwards BE THV.
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
Interventions
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Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
Eligibility Criteria
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Inclusion Criteria
* Subject has a predicted risk of operative mortality \< 15% as determined by the local Heart Team
* Subject has severe aortic stenosis as determined by transthoracic echocardiography (TTE) at rest
* Subject has a small aortic annulus as determined by Multi-detector computed tomography (MDCT)
* Subject's anatomy is appropriate for both Medtronic Evolut PRO/PRO+/FX TAV and Edwards SAPIEN 3/3 Ultra TAV
* Subject's anatomy is suitable for TAVR via transfemoral vessel access
* Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
Exclusion Criteria
* Multivessel coronary artery disease with a Syntax score \>32 and/or unprotected left main coronary artery(Syntax score calculation is not required for patients with history of previous revascularization if repeat revascularization is not planned).
* Participating in another trial that may influence the outcome of this trial
* Need for an emergent procedure for any reason
* Contraindicated for treatment with the Evolut PRO/PRO+/FX and Edwards SAPIEN 3/3 Ultra TAV in accordance with the Instructions for Use
* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams
* Pregnant, nursing, or planning to be pregnant
* Subject is less than the legal age of consent, legally incompetent, unable to provide his/her own informed consent, or otherwise vulnerable
* Subject has an active COVID-19 infection or relevant history of COVID-19
* Previous aortic valve replacement
18 Years
ALL
No
Sponsors
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Medtronic Cardiovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Herrmann, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania, United States
Roxana Mehran, MD
Role: PRINCIPAL_INVESTIGATOR
Mount Sinai School of Medicine, United States
Didier Tchétché, MD
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur Toulouse, France
Locations
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Scripps Memorial Hospital
La Jolla, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Sutter Health
San Francisco, California, United States
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
University of Colorado
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
WHC Washington MedStar
Washington D.C., District of Columbia, United States
Morton Plant Hospital
Clearwater, Florida, United States
HealthPark Medical Center
Fort Myers, Florida, United States
University of Florida
Gainesville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Emory Structural Heart Clinic and Emory University Midtown
Atlanta, Georgia, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
NorthShore Health Systems
Evanston, Illinois, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, United States
Saint Vincent Heart Center of Indiana
Carmel, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
AscensionVia Christi St. Francis Hospital
Wichita, Kansas, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Cloud Hospital
Saint Cloud, Minnesota, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
Buffalo General Medical Center
Buffalo, New York, United States
NYU Langone Medical Center
New York, New York, United States
The Icahn School of Medicine at Mount Sinai
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
Mission Hospital
Asheville, North Carolina, United States
UNC Memorial Hospital
Chapel Hill, North Carolina, United States
TriHealth / Bethesda North Hospital
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
St. Thomas West Hospital
Nashville, Tennessee, United States
Seton Heart Institute
Austin, Texas, United States
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Dallas, Texas, United States
Texas Health Presbyterian Hospital/Dallas
Dallas, Texas, United States
Baylor Saint Luke's Hospital
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure
Houston, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
Intermountain Medical Center
Murray, Utah, United States
Saint George Regional Hospital
St. George, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
J.W. Ruby Memorial Hospital/West Virginia University
Morgantown, West Virginia, United States
Providence Health-St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Heart Institute Foundation/Royal Jubilee Hospital
Victoria, British Columbia, Canada
Toronto General Hospital
Toronto, Ontario, Canada
St. Michaels Hospital/Unity Health Toronto
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Rigshospitalet
Copenhagen, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
CHU Bordeaux
Pessac, , France
Clinique Pasteur
Toulouse, , France
Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund
Dortmund, , Germany
Universitätsklinikum Düsseldorf
Düsseldorf, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, , Germany
Helios Health Institute GmbH
Leipzig, , Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, , Germany
Deutsches Herzzentrum Munchen
München, , Germany
Sheba Medical Center
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Policlinico Sant' Orsala - Malpighi
Bologna, , Italy
Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
Pisa, , Italy
AOU Integrata Verona
Verona, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht, , Netherlands
HagaZiekenhuis - Locatie Leyweg
The Hague, , Netherlands
Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
Carnaxide, , Portugal
Hospital Vall d'Hebron
Barcelona, , Spain
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
Leeds, , United Kingdom
Countries
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References
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Tchetche D, Mehran R, Blackman DJ, Khalil RF, Mollmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Bleiziffer S, Lin L, Szerlip M, Grubb KJ, Byku I, Guerrero M, Gillam LD, Petronio AS, Attizzani GF, Batchelor WB, Gada H, Rogers T, Rovin JD, Whisenant B, Benton S, Gardner B, Padang R, Althouse AD, Herrmann HC. Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. 2024 Dec 1;9(12):1106-1114. doi: 10.1001/jamacardio.2024.3241.
Herrmann HC, Mehran R, Blackman DJ, Bailey S, Mollmann H, Abdel-Wahab M, Ben Ali W, Mahoney PD, Ruge H, Wood DA, Bleiziffer S, Ramlawi B, Gada H, Petronio AS, Resor CD, Merhi W, Garcia Del Blanco B, Attizzani GF, Batchelor WB, Gillam LD, Guerrero M, Rogers T, Rovin JD, Szerlip M, Whisenant B, Deeb GM, Grubb KJ, Padang R, Fan MT, Althouse AD, Tchetche D; SMART Trial Investigators. Self-Expanding or Balloon-Expandable TAVR in Patients with a Small Aortic Annulus. N Engl J Med. 2024 Jun 6;390(21):1959-1971. doi: 10.1056/NEJMoa2312573. Epub 2024 Apr 7.
Herrmann HC, Abdel-Wahab M, Attizzani GF, Batchelor W, Bleiziffer S, Verdoliva S, Chang Y, Gada H, Gillam L, Guerrero M, Mahoney PD, Petronio AS, Rogers T, Rovin J, Szerlip M, Whisenant B, Mehran R, Tchetche D. Rationale and design of the SMall Annuli Randomized To Evolut or SAPIEN Trial (SMART Trial). Am Heart J. 2022 Jan;243:92-102. doi: 10.1016/j.ahj.2021.09.011. Epub 2021 Sep 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MDT20023EVR012
Identifier Type: -
Identifier Source: org_study_id
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