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SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial
NCT04722250 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04722250
The ClinicalTrials.gov registry entry for NCT04722250 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,103 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiovascular, which has 49 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04722250 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04722250?
This trial is sponsored by Medtronic Cardiovascular, which has 49 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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