| NCT ID | NCT04898335 |
| Status | Recruiting |
| Phase | — |
| Sponsor | LMU Klinikum |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2021-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2021-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Joerg Hausleiter, MD
PRINCIPAL INVESTIGATOR
LMU Klinikum Munich
Frequently Asked Questions
Who can join the NCT04898335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04898335 currently recruiting?
Yes, NCT04898335 is actively recruiting participants. Contact the research team at joerg.hausleiter@med.uni-muenchen.de for enrollment information.
Where is the NCT04898335 trial being conducted?
This trial is being conducted at Linz, Austria, Vienna, Austria, Leuven, Belgium, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT04898335 clinical trial?
NCT04898335 is sponsored by LMU Klinikum. The principal investigator is Joerg Hausleiter, MD at LMU Klinikum Munich. The trial plans to enroll 400 participants.