NCT04914468 Hamburg TranscathEteR Mitral Valve REplacement RegiStry
| NCT ID | NCT04914468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf |
| Condition | Mitral Valve Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-03-08 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 300 participants in total. It began in 2021-03-08 with a primary completion date of 2030-12-31.
⚠ 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
The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.
Eligibility Criteria
Inclusion Criteria: * Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation. * Individuals over the age of 18 years. * Patients with clinically relevant mitral valve disease, who undergo screening for TMVR. Exclusion Criteria: * Insufficient knowledge of the German language, to understand study documents and interview without translation * Physical or psychological incapability to cooperate in the investigation
Contact & Investigator
Sebastian Ludwig, MD
PRINCIPAL INVESTIGATOR
University Heart and Vascular Center Hamburg
Frequently Asked Questions
Who can join the NCT04914468 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 110 Years, studying Mitral Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04914468 currently recruiting?
Yes, NCT04914468 is actively recruiting participants. Contact the research team at se.ludwig@uke.de for enrollment information.
Where is the NCT04914468 trial being conducted?
This trial is being conducted at Hamburg, Germany.
Who is sponsoring the NCT04914468 clinical trial?
NCT04914468 is sponsored by Universitätsklinikum Hamburg-Eppendorf. The principal investigator is Sebastian Ludwig, MD at University Heart and Vascular Center Hamburg. The trial plans to enroll 300 participants.