- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04722250
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial (SMART)
The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.
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.
Study Overview
Status
Detailed Description
This is a prospective, multi-center, international, randomized controlled, post-market trial.
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- Providence Health-St. Paul's Hospital
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Victoria, British Columbia, Canada
- Victoria Heart Institute Foundation/Royal Jubilee Hospital
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, Canada
- St. Michaels Hospital/Unity Health Toronto
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Quebec
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Montréal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
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Copenhagen, Denmark
- Rigshospitalet
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Helsinki, Finland
- Helsinki University Hospital
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Clermont-Ferrand, France
- Centre Hospitalier Universitaire de Clermont-Ferrand
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Pessac, France
- CHU Bordeaux
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Toulouse, France
- Clinique Pasteur
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Bad Oeynhausen, Germany
- Hers-und Diabeteszentrum NRW - Ruhr -Universitati Bochum
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Berlin, Germany
- Deutsches Herzzentrum Berlin
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Dortmund, Germany
- Kath. St.-Johannes-Gesellschaft Dortmund gGmbH - St. Johannes-Hospital Dortmund
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Düsseldorf, Germany
- Universitätsklinikum Düsseldorf
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Kiel, Germany
- Universitätsklinikum Schleswig-Holstein - Campus Kiel
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Leipzig, Germany
- Helios Health Institute GmbH
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Lübeck, Germany
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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München, Germany
- Deutsches Herzzentrum München
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Ramat Gan, Israel
- Sheba Medical Center
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Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center
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Bologna, Italy
- Policlinico Sant' Orsala - Malpighi
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Pisa, Italy
- Azienda Ospedaliero-Universitaria Pisana - Stabilimento di Cisanello
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Verona, Italy
- AOU Integrata Verona
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Den Haag, Netherlands
- HagaZiekenhuis - Locatie Leyweg
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Eindhoven, Netherlands
- Catharina Ziekenhuis
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Maastricht, Netherlands
- Maastricht Universitair Medisch Centrum (MUMC)
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Carnaxide, Portugal
- Centro Hospitalar de Lisboa Ocidental, E.P.E. Hospital de Santa Cruz
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Barcelona, Spain
- Hospital Vall d'Hebron
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Bern, Switzerland
- Inselspital - Universitätsspital Bern
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Edinburgh, United Kingdom
- Royal Infirmary of Edinburgh
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Leeds, United Kingdom
- The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
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California
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La Jolla, California, United States, 92037
- Scripps Memorial Hospital
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Los Angeles, California, United States, 90048
- Cedars Sinai Medical Center
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San Francisco, California, United States, 94109
- Sutter Health
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Thousand Oaks, California, United States, 91360
- Los Robles Hospital and Medical Center
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale New Haven Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20010
- WHC Washington MedStar
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Florida
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Clearwater, Florida, United States, 33756
- Morton Plant Hospital
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Fort Myers, Florida, United States, 33908
- HealthPark Medical Center
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Gainesville, Florida, United States, 32608
- University of Florida
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Miami Beach, Florida, United States, 33140
- Mount Sinai Medical Center
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Georgia
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Atlanta, Georgia, United States, 30309
- Piedmont Atlanta Hospital
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Atlanta, Georgia, United States, 30308
- Emory Structural Heart Clinic and Emory University Midtown
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Marietta, Georgia, United States, 30060
- Wellstar Kennestone Hospital
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Illinois
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Evanston, Illinois, United States, 60201
- NorthShore Health Systems
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Oak Lawn, Illinois, United States, 60453
- Advocate Christ Medical Center
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Indiana
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Carmel, Indiana, United States, 46290
- Saint Vincent Heart Center of Indiana
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Wichita, Kansas, United States, 67226
- AscensionVia Christi St. Francis Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Detroit, Michigan, United States, 48236
- Ascension St. John Hospital
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Grand Rapids, Michigan, United States, 49503
- Spectrum Health
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Saint Cloud, Minnesota, United States, 56303
- St. Cloud Hospital
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Missouri
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Saint Louis, Missouri, United States, 63131
- Missouri Baptist Medical Center
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New Jersey
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Morristown, New Jersey, United States, 07960
- Morristown Medical Center
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New York
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Buffalo, New York, United States, 14203
- Buffalo General Medical Center
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New York, New York, United States, 10016
- NYU Langone Medical Center
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New York, New York, United States, 10065
- Weill Cornell Medical Center
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New York, New York, United States, 10029
- The Icahn School of Medicine at Mount Sinai
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital
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Chapel Hill, North Carolina, United States, 27599
- UNC Memorial Hospital
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Ohio
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Cincinnati, Ohio, United States, 45220
- TriHealth / Bethesda North Hospital
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Oklahoma
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Tulsa, Oklahoma, United States, 74104
- Hillcrest Medical Center
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Pennsylvania
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Harrisburg, Pennsylvania, United States, 17110
- UPMC Pinnacle Harrisburg
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Presbyterian
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Wynnewood, Pennsylvania, United States, 19096
- Lankenau Medical Center
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York, Pennsylvania, United States, 17403
- York Hospital
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Tennessee
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Nashville, Tennessee, United States, 37203
- TriStar Centennial Medical center
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Nashville, Tennessee, United States, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, United States, 78705
- Seton Heart Institute
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Dallas, Texas, United States, 75226
- Baylor Jack and Jane Hamilton Heart and Vascular Hospital
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Dallas, Texas, United States, 76231
- Texas Health Presbyterian Hospital/Dallas
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Houston, Texas, United States, 77030
- Houston Methodist Hospital
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Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
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Houston, Texas, United States, 77030
- Baylor Saint Luke's Hospital
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Houston, Texas, United States, 77030
- University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure
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Plano, Texas, United States, 75093
- The Heart Hospital Baylor Plano
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Utah
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Murray, Utah, United States, 84107
- Intermountain Medical Center
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Saint George, Utah, United States, 84770
- Saint George Regional Hospital
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Virginia
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Charlottesville, Virginia, United States, 22903
- University of Virginia
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Hospital
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Norfolk, Virginia, United States, 23507
- Sentara Norfolk General Hospital
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West Virginia
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Morgantown, West Virginia, United States, 26506
- J.W. Ruby Memorial Hospital/West Virginia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Heart Team agrees that the subject is deemed symptomatic and is a candidate for transcatheter aortic valve replacement (TAVR)
- 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:
- Estimated life expectancy of fewer than 2 years
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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TAVR treatment with Medtronic Evolut PRO, PRO+ System or Evolut FX System (where commercially available)
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Experimental: 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.
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TAVR treatment with Edwards SAPIEN 3 or SAPIEN 3 Ultra System
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality, disabling stroke or heart failure rehospitalization
Time Frame: 12 months
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Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
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12 months
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Bioprosthetic Valve Dysfunction (BVD)
Time Frame: 12 months
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Percentage of participants with BVD (hemodynamic structural valve dysfunction, non-structural valve dysfunction, thrombosis, endocarditis, or aortic valve re-intervention) at 12 months.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Percentage of participants with BVD in female subjects
Time Frame: 12 months
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12 months
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Percentage of participants with Hemodynamic Structural Valve Dysfunction (HSVD)
Time Frame: 12 months
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12 months
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Aortic valve mean gradient as a continuous variable
Time Frame: 12 months
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12 months
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Effective Orifice Area (EOA) as a continuous variable
Time Frame: 12 months
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12 months
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Rate of moderate or severe prothesis-patient mismatch (PPM)
Time Frame: 30 days
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30 days
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device success
Time Frame: 30 days
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30 days
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Incidence of an early safety composite
Time Frame: 30 days
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Incidence of an early safety composite at 30 days defined as:
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30 days
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Hospital readmission rate for any cause
Time Frame: 30 days
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30 days
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Incidence of clinical efficacy
Time Frame: 12 months and annually through 5 years
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Incidence of clinical efficacy (after 30 days) at 12 months and annually to 5 years defined as a composite of:
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12 months and annually through 5 years
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Percentage of participants with individual clinical endpoint components including mortality, disabling stroke and heart failure rehospitalization
Time Frame: 12 months and annually to 5 years
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12 months and annually to 5 years
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New pacemaker implantation rate
Time Frame: 30 days, 12 months and annually to 5 years
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30 days, 12 months and annually to 5 years
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Aortic valve re-intervention rate
Time Frame: 30 days, 12 months and annually to 5 years
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30 days, 12 months and annually to 5 years
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6-minute walk test (6MWT) change from baseline
Time Frame: 30 days, 12 months and annually to 5 years
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30 days, 12 months and annually to 5 years
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Quality of Life (QoL) change from baseline (Kansas City Cardiomyopathy Questionnaire [KCCQ]
Time Frame: 30 days, 12 months and annually to 5 years
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QoL: KCCQ
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30 days, 12 months and annually to 5 years
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Quality of Life (QoL) change from baseline EuroQol- 5 Dimension [EQ-5D])
Time Frame: 30 days, 12 months and annually to 5 years
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QoL: EQ-5D
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30 days, 12 months and annually to 5 years
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BVD
Time Frame: 2 to 5 years annually
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BVD at 2 to 5 years annually post-procedure including any of the following:
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2 to 5 years annually
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Echocardiographic measurements
Time Frame: Discharge, 30 days, 12 months and annually to 5 years
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Echocardiographic measurements (i.e.
EOA, mean gradient, peri-valvular leak (PVL), left ventricular mass regression, and DVI (severe <0.25, moderate 0.25-0.5,
mild >0.5)).
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Discharge, 30 days, 12 months and annually to 5 years
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Mean gradient ≥ 20 mmHg based on stress echocardiogram
Time Frame: 12 months
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Mean gradient ≥ 20 mmHg based on stress echocardiogram at select sites.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Howard Herrmann, MD, University of Pennsylvania, United States
- Principal Investigator: Roxana Mehran, MD, Mount Sinai School of Medicine, United States
- Principal Investigator: Didier Tchétché, MD, Clinique Pasteur Toulouse, France
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT20023EVR012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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