Registry for the Tendyne Mitral Valve System in patients with mitral regurgitation
TENDyne European expeRience Registry
This study is testing the Tendyne Mitral Valve System to see if it is safe and effective for people with severe mitral regurgitation who can't have traditional surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | LMU Klinikum Academic / other |
| Locations | 30 sites (Linz and 29 other locations) |
| Trial ID | NCT04898335 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of the Tendyne Mitral Valve System in patients with severe mitral regurgitation. It includes both retrospective and prospective data collection from multiple centers to evaluate early outcomes at 30 days, as well as clinical outcomes at 1 and 3 years post-treatment. The study will also identify echocardiographic and CT-based anatomical predictors that may influence patient outcomes. The Tendyne system is a transcatheter valve prosthesis designed for patients who are often ineligible for traditional surgical options due to age or comorbidities.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe mitral regurgitation who have been treated with the Tendyne Mitral Valve System in a commercial setting.
Not a fit: Patients who do not provide written informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of the Tendyne Mitral Valve System, potentially improving treatment options for patients with severe mitral regurgitation.
How similar studies have performed: Previous studies have shown safety and feasibility for the Tendyne Mitral Valve System, but this study aims to gather real-world data, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients treated with the Tendyne Mitral Valve System for mitral valve disease in a commercial setting * Patients providing written informed consent in compliance with the protocol, the ICH-GCP and all national legal and regulatory requirements Exclusion Criteria: * Patients not providing written informed consent
Where this trial is running
Linz and 29 other locations
- Universitaetsklinikum Linz — Linz, Austria (Recruiting)
- Universitaetsklinikum Wien — Vienna, Austria (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- CHU de Lille — Lille, France (Recruiting)
- CHU Rennes — Rennes, France (Not_yet_recruiting)
- Clinique Pasteur — Toulouse, France (Recruiting)
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (Recruiting)
- Deutsches Herzzentrum Berlin — Berlin, Germany (Recruiting)
- Universitaetsklinikum Bonn — Bonn, Germany (Recruiting)
- Universitaetsklinikum Koeln — Cologne, Germany (Recruiting)
- Universitätsklinikum Frankfurt — Frankfurt, Germany (Recruiting)
- UKE Hamburg — Hamburg, Germany (Recruiting)
- Herzentrum Leipzig — Leipzig, Germany (Not_yet_recruiting)
- Universitätsmedizin Mainz — Mainz, Germany (Recruiting)
- DHZ München — Münich, Germany (Recruiting)
- Universitaetsklinikum Regensburg — Regensburg, Germany (Not_yet_recruiting)
- Robert-Bosch-Krankenhaus Stuttgart — Stuttgart, Germany (Not_yet_recruiting)
- Universitaetsklinikum Tuebingen — Tübingen, Germany (Recruiting)
- ICH - Istituto Clinico Humanitas — Milan, Italy (Recruiting)
- University Hospital of Pisa — Pisa, Italy (Recruiting)
- University hospital Oslo — Oslo, Norway (Recruiting)
- Puerto de Hierro Madrid — Madrid, Spain (Recruiting)
- University hospital Madrid — Madrid, Spain (Recruiting)
- Hospital Clinico Valladolid — Valladolid, Spain (Recruiting)
- University Hospital of Vigo — Vigo, Spain (Recruiting)
- Karolinska University Stockholm — Stockholm, Sweden (Not_yet_recruiting)
- Universitaetsspital Basel — Basel, Switzerland (Not_yet_recruiting)
- Inselspital Bern — Bern, Switzerland (Recruiting)
- Royal Brompton London — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Joerg Hausleiter, MD — LMU Klinikum Munich
- Study coordinator: Joerg Hausleiter, MD
- Email: joerg.hausleiter@med.uni-muenchen.de
- Phone: 0049894400
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.