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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: Recruiting NA study of Mitral Valve Regurgitation, sponsored by Annetine Gelijns.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention. Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and posi
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 |
What NCT05051033 shows while recruiting
NCT05051033 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 773-participant average among 11 other Mitral Valve Regurgitation trials with a reported enrollment target (42% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Mitral Valve Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05051033's enrollment target sits among peer trials
450 6th of 11 higher than 5 of 11 other Mitral Valve Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Valve Regurgitation 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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