SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
Public ClinicalTrials.gov record NCT04722250. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04722250
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,103 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2021 (Actual)
- Primary completion
- Nov 10, 2023 (Actual)
- Completion
- Dec 2027 (Estimated)
- Last update posted
- Jun 2, 2026
2021 – 2027
United States locations
- U.S. sites
- 61
- U.S. states
- 25
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scripps Memorial Hospital | La Jolla | California | 92037 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Sutter Health | San Francisco | California | 94109 | — |
| Los Robles Hospital and Medical Center | Thousand Oaks | California | 91360 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| WHC Washington MedStar | Washington D.C. | District of Columbia | 20010 | — |
| Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| HealthPark Medical Center | Fort Myers | Florida | 33908 | — |
| University of Florida | Gainesville | Florida | 32608 | — |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| Emory Structural Heart Clinic and Emory University Midtown | Atlanta | Georgia | 30308 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | — |
| NorthShore Health Systems | Evanston | Illinois | 60201 | — |
| Advocate Christ Medical Center | Oak Lawn | Illinois | 60453 | — |
| Saint Vincent Heart Center of Indiana | Carmel | Indiana | 46290 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| AscensionVia Christi St. Francis Hospital | Wichita | Kansas | 67226 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Ascension St. John Hospital | Detroit | Michigan | 48236 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | — |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Buffalo General Medical Center | Buffalo | New York | 14203 | — |
| NYU Langone Medical Center | New York | New York | 10016 | — |
| The Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Weill Cornell Medical Center | New York | New York | 10065 | — |
| Mission Hospital | Asheville | North Carolina | 28801 | — |
| UNC Memorial Hospital | Chapel Hill | North Carolina | 27599 | — |
| TriHealth / Bethesda North Hospital | Cincinnati | Ohio | 45220 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Hillcrest Medical Center | Tulsa | Oklahoma | 74104 | — |
| UPMC Pinnacle Harrisburg | Harrisburg | Pennsylvania | 17110 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| Lankenau Medical Center | Wynnewood | Pennsylvania | 19096 | — |
| York Hospital | York | Pennsylvania | 17403 | — |
| TriStar Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| St. Thomas West Hospital | Nashville | Tennessee | 37205 | — |
| Seton Heart Institute | Austin | Texas | 78705 | — |
| Baylor Jack and Jane Hamilton Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Texas Health Presbyterian Hospital/Dallas | Dallas | Texas | 76231 | — |
| Baylor Saint Luke's Hospital | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| University of Texas Health Sciences Center at Houston - Center for Advanced Heart Failure | Houston | Texas | 77030 | — |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| Saint George Regional Hospital | St. George | Utah | 84770 | — |
| University of Virginia | Charlottesville | Virginia | 22903 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | — |
| J.W. Ruby Memorial Hospital/West Virginia University | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04722250, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 2, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04722250 live on ClinicalTrials.gov.