Registry for the Tendyne Mitral Valve System in patients with mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Universitaetsklinikum Linz
  Linz, Austria Recruiting
• Universitaetsklinikum Wien
  Vienna, Austria Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• CHU de Lille
  Lille, France Recruiting
• Clinique Pasteur
  Toulouse, France Recruiting
• Herz- und Diabeteszentrum NRW
  Bad Oeynhausen, Germany 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.