Registry for patients treated with the MitraClip System in Belgium
Belgian Mitraclip Registry
This study is tracking patients in Belgium who are treated with the MitraClip System for severe mitral valve problems to see how well it works and help doctors make better treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 25 Years to 90 Years |
| Sex | All |
| Sponsor | Universiteit Antwerpen Academic / other |
| Locations | 2 sites (Edegem, Antwerp and 1 other locations) |
| Trial ID | NCT02506387 on ClinicalTrials.gov |
What this trial studies
This registry aims to investigate and follow all patients in Belgium who are treated with the MitraClip System for severe mitral valve insufficiency. It seeks to establish the clinical value of MitraClip therapy and provide practical information to aid physicians in treatment decisions, hospitals in purchasing decisions, and insurers/government in coverage decisions. Additionally, national data will be shared with European registries to enhance understanding of the efficacy of this innovative technique.
Who should consider this trial
Good fit: Ideal candidates include patients with severe symptomatic mitral regurgitation who are not candidates for cardiac surgery.
Not a fit: Patients with a life expectancy of less than one year may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could improve treatment selection and outcomes for patients with severe mitral regurgitation.
How similar studies have performed: Other registries and studies have shown success in evaluating the efficacy of the MitraClip technique, indicating a growing body of evidence supporting its use.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * severe mitral regurgitation * symptomatic (NYHA class\>1) despite optimal medical therapy * suitable anatomy for mitraclip implantation * too high risk for cardiac surgery Exclusion Criteria: * \<1 year life expectancy
Where this trial is running
Edegem, Antwerp and 1 other locations
- University hospital Antwerp — Edegem, Antwerp, Belgium (Recruiting)
- OLV Aalst — Aalst, Belgium (Recruiting)
Study contacts
- Study coordinator: Marc Claeys, MD, PhD
- Email: marc.claeys@uantwerpen.be
- Phone: 003238214706
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.