Registry for treating severe tricuspid valve issues
German Registry for Transcatheter Tricuspid Valve Interventions
This study looks at how well different treatments work for people with severe tricuspid valve problems who can't have surgery because of high risks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 1 site (Munich) |
| Trial ID | NCT04653428 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study focuses on patients with severe tricuspid regurgitation who are undergoing interventional treatment. It aims to analyze the success and safety of various interventional repair techniques for this condition, which is often associated with significant morbidity and mortality. Clinical, echocardiographic, and laboratory parameters will be collected to evaluate the outcomes of these treatments. The study is designed to provide insights into alternative treatment options for patients who are not eligible for surgical repair due to high mortality risk.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe tricuspid regurgitation who are undergoing interventional treatment with a CE certified product.
Not a fit: Patients who are under 18 years of age or who do not agree to participate will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable data on effective interventional treatments for patients with severe tricuspid regurgitation, potentially improving their quality of life and survival rates.
How similar studies have performed: Other studies have explored interventional treatments for heart valve diseases, showing promising results, but this specific approach for tricuspid regurgitation is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair * Informed consent corresponding to criteria of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission. Exclusion Criteria: * No agreement to participation * Age \< 18 years
Where this trial is running
Munich
- Klinikum der LMU Muenchen — Munich, Germany (Recruiting)
Study contacts
- Principal investigator: Jörg Hausleiter, MD — Klinikum der LMU Muenchen
- Study coordinator: Jörg Hausleiter, MD
- Email: joerg.hausleiter@med.uni-muenchen.de
- Phone: +49 89 4400 72361
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.