Registry for patients undergoing MitraClip® procedure for mitral regurgitation
MitraClip® Registry - an Observational Study of Percutaneous Mitral Valve Repair Using the MitraClip® System
Heinrich-Heine University, Duesseldorf · NCT02033811
This study collects information from patients with severe mitral regurgitation who are treated with the MitraClip® procedure to see how well it works and how safe it is for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf (other) |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT02033811 on ClinicalTrials.gov |
What this trial studies
This registry collects clinical data from patients with severe mitral regurgitation who are treated with the MitraClip® system, a minimally invasive procedure for mitral valve repair. The aim is to systematically assess patient characteristics and outcomes following percutaneous mitral valve repair (PMVR). By gathering this information, the registry seeks to enhance understanding of the procedure's effectiveness and safety in high-risk patients. It is an observational study, meaning it will monitor real-world outcomes without altering the treatment process.
Who should consider this trial
Good fit: Ideal candidates are adults with severe mitral regurgitation who are undergoing PMVR with the MitraClip® system.
Not a fit: Patients under 18 years old or those deemed unlikely to benefit from the procedure by the heart team will not receive benefit from this study.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies and outcomes for patients with severe mitral regurgitation.
How similar studies have performed: Other studies on percutaneous mitral valve repair have shown promising results, indicating that this approach is gaining acceptance in clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe mitral regurgitation * percutaneous mitral valve repair (PMVR) with the MitraClip® system Exclusion Criteria: * \< 18 years * Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure
Where this trial is running
Düsseldorf
- Heinrich Heine University Div. of Cardiology, Pulmonary Disease and Vasculae Medicine — Düsseldorf, Germany (RECRUITING)
Study contacts
- Principal investigator: Malte Kelm, MD — Division of Cardiology, Pulmonary Disease and Vascular Medicine
- Study coordinator: Malte Kelm, MD
- Phone: 0049 211 81 18800
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.
Conditions: Mitral Regurgitation, mitral regurgitation, MitraClip system, percutaneous mitral valve repair