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NCT04722250 · ClinicalTrials.gov registry record · NA
SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
A NA study of Aortic Valve Stenosis and Aortic Valve Replacement, sponsored by Medtronic Cardiovascular.
- Active
- Registry status
- NA
- Development phase
- 1,103
- Enrollment target
- 20
- Study locations
NCT04722250: Active NA study of Aortic Valve Stenosis and Aortic Valve Replacement, sponsored by Medtronic Cardiovascular.
NCT04722250 is a NA study of Aortic Valve Stenosis and Aortic Valve Replacement that is active but no longer recruiting, run by Medtronic Cardiovascular. The registered enrollment target is 1,103 participants, above the 1,006-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (10% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722250, a NA study of Aortic Valve Stenosis and Aortic Valve Replacement, is active but no longer recruiting, sponsored by Medtronic Cardiovascular.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,103 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Percentage of participants with all-cause mortality, disabling stroke, or heart failure rehospitalization.
Conditions Studied
Interventions
- DEVICE Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
- DEVICE Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems
Study Locations (20)
California
- Scripps Memorial Hospital - La Jolla
- Cedars Sinai Medical Center - Los Angeles
- Sutter Health - San Francisco
- Los Robles Hospital and Medical Center - Thousand Oaks
Florida
- Morton Plant Hospital - Clearwater
- HealthPark Medical Center - Fort Myers
- University of Florida - Gainesville
- Mount Sinai Medical Center - Miami Beach
Georgia
- Emory Structural Heart Clinic and Emory University Midtown - Atlanta
- Piedmont Atlanta Hospital - Atlanta
- Wellstar Kennestone Hospital - Marietta
Illinois
- NorthShore Health Systems - Evanston
- Advocate Christ Medical Center - Oak Lawn
Kansas
- University of Kansas Medical Center - Kansas City
- AscensionVia Christi St. Francis Hospital - Wichita
Colorado
- University of Colorado - Aurora
Connecticut
- Yale New Haven Hospital - New Haven
District of Columbia
- WHC Washington MedStar - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,103 participants |
| Start Date | 2021-04-02 |
| Est. Completion | 2027-12 |
| Phase | NA |
What the registry record for NCT04722250 still lists
NCT04722250 is an interventional study that assigns participants to a tested intervention. Its 1,103 participants enrollment target places it among the larger protocols in the corpus, above the 1,006-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (10% higher).
The record links to 3 conditions, with Aortic Valve Stenosis appearing as the primary indexed condition, and to 2 interventions - of which Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems is the first listed.
NCT04722250 names 20 study sites across 10 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04722250 about?
NCT04722250 is a clinical study titled "SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial". 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 stres...
What is the current status of trial NCT04722250?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,103 participants. The study started on 2021-04-02. Estimated completion is 2027-12.
What conditions does trial NCT04722250 study?
This clinical trial studies the following conditions: Aortic Valve Stenosis, Aortic Valve Replacement, Symptomatic Aortic Stenosis.
What interventions are being tested in trial NCT04722250?
The interventions under investigation include: Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems (DEVICE), Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems (DEVICE).
Who is sponsoring clinical trial NCT04722250?
This trial is sponsored by Medtronic Cardiovascular, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04722250 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04722250's enrollment target sits among peer trials
1,103 7th of 30 higher than 24 of 30 other Aortic Valve Stenosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Aortic Valve Stenosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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