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NCT05051033 · ClinicalTrials.gov registry record · NA
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
A NA study of Mitral Valve Regurgitation, sponsored by Annetine Gelijns.
- Recruiting
- Registry status
- NA
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT05051033 is a NA study of Mitral Valve Regurgitation that is actively recruiting participants, run by Annetine Gelijns. The registered enrollment target is 450 participants, below the 773-participant average among 11 other Mitral Valve Regurgitation trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT05051033, a NA study of Mitral Valve Regurgitation, is actively recruiting participants, sponsored by Annetine Gelijns.
- RECRUITING
- Registry status
- NA
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.
Conditions Studied
Interventions
- DEVICE Transcatheter edge-to-edge repair
- PROCEDURE Mitral valve repair
Study Locations (20)
California
- Keck Hospital of the University of Southern California - Los Angeles
- Cedars Sinai Medical Center - Los Angeles
- University of California San Francisco - San Francisco
- Stanford University - Stanford
New York
- New York-Presbyterian/Columbia University Medical Center - New York
- Weill Cornell Medicine/ New York-Presbyterian Hospital - New York
- Northwell Health - New York
Georgia
- Piedmont Heart Institute - Atlanta
- Emory University - Atlanta
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham and Women's - Boston
Louisiana
- Ochsner Clinic - New Orleans
Maine
- Maine Medical Center - Portland
Maryland
- The Johns Hopkins Hospital - Baltimore
Michigan
- University of Michigan Hospital - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2022-02-21 |
| Est. Completion | 2030-11-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05051033
The ClinicalTrials.gov registry entry for NCT05051033 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 773-participant average among 11 other Mitral Valve Regurgitation trials with a reported enrollment target (42% lower). The listed sponsor is Annetine Gelijns, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Mitral Valve Regurgitation appearing as the primary indexed condition, and to 2 interventions - of which Transcatheter edge-to-edge repair is the first listed.
NCT05051033 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, New York, Georgia.
Frequently Asked Questions
What is clinical trial NCT05051033 about?
NCT05051033 is a clinical study titled "Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)". This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and ...
What is the current status of trial NCT05051033?
This trial is currently recruiting. It is a NA study. The enrollment target is 450 participants. The study started on 2022-02-21. Estimated completion is 2030-11-15.
What conditions does trial NCT05051033 study?
This clinical trial studies the following conditions: Mitral Valve Regurgitation.
What interventions are being tested in trial NCT05051033?
The interventions under investigation include: Transcatheter edge-to-edge repair (DEVICE), Mitral valve repair (PROCEDURE).
Who is sponsoring clinical trial NCT05051033?
This trial is sponsored by Annetine Gelijns, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05051033 being conducted?
This trial has 20 study locations across California, Georgia, Louisiana, Maine, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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.