Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
NCT05051033 · View on ClinicalTrials.gov ↗
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 |
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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. 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 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Annetine Gelijns, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT05051033 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, New York, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05051033?
The interventions under investigation include: Transcatheter edge-to-edge repair (DEVICE), Mitral valve repair (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05051033?
This trial is sponsored by Annetine Gelijns, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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