Investigating outcomes of mitral valve repair for severe regurgitation
Outcomes of Patients tReated wIth Mitral Transcatheter Edge-to-edge Repair for Primary Mitral Regurgitation Registry
This study looks at how well a special heart procedure called mitral valve repair works for people with severe heart valve problems over a year after their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 6 sites (New York, New York and 5 other locations) |
| Trial ID | NCT05332782 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the outcomes of patients who have undergone mitral valve transcatheter edge-to-edge repair (M-TEER) for primary mitral regurgitation (PMR). It is a multinational, non-interventional, and retrospective analysis that collects data from various medical centers. The study focuses on patients with clinically significant PMR and requires echocardiography data at baseline, during the procedure, and at follow-up, with a minimum follow-up period of 12 months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with clinically significant primary mitral regurgitation who have undergone M-TEER.
Not a fit: Patients under 18 years of age will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and long-term outcomes of M-TEER for patients with primary mitral regurgitation.
How similar studies have performed: Other studies have shown promising results with similar approaches in treating mitral regurgitation, indicating that this methodology has been tested with some success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically significant primary mitral regurgitation * patient underwent M-TEER * echocardiography data at baseline, procedure and follow-up * follow-up of at least 12 months Exclusion Criteria * age under 18 years
Where this trial is running
New York, New York and 5 other locations
- Montefiore Medical Center — New York, New York, United States (Recruiting)
- Centre Hospitalier de Bordeaux — Bordeaux, France (Recruiting)
- Université Lille, Inserm, Centre Hospitalier Universitaire de Lille — Lille, France (Recruiting)
- University Hospital of Rennes, Centre Hospitalier de Rennes — Rennes, France (Recruiting)
- University Heart & Vascular Center Hamburg — Hamburg, Germany (Recruiting)
- Klinikum der Universität München — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Daniel Kalbacher, MD — University Heart & Vascular Center Hamburg
- Study coordinator: Benedikt Koell, MD
- Email: b.koell@uke.de
- Phone: +4915222815230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.