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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 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.

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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.

Conditions Studied

Aortic Valve Stenosis Aortic Valve Replacement Symptomatic Aortic Stenosis

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

FieldValue
Enrollment Target 1,103 participants
Start Date 2021-04-02
Est. Completion 2027-12
Phase NA

Sponsor

Medtronic Cardiovascular

44 total trials

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What the Registry Record Tells You About NCT04722250

The ClinicalTrials.gov registry entry for NCT04722250 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 1,103 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 1,006-participant average among 30 other Aortic Valve Stenosis trials with a reported enrollment target (10% higher). The listed sponsor is Medtronic Cardiovascular, which has 44 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.