Trial Parameters
Condition Mitral Regurgitation
Sponsor LMU Klinikum
Study Type OBSERVATIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-04-15
Completion 2026-12-31
Interventions
Tendyne Mitral Valve System
Brief Summary
TENDER is a multicenter, single-device, retrospective and prospective, observational study to assess safety and efficacy of the Tendyne Mitral Valve System in a real-world population.
Eligibility 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