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NCT04577248 Clinical Trial

The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Mitral Valve Regurgitation Clinical Trial

— OBSERV-MITRA  

Official title:
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04577248
Other study ID # GE DHM-AN-EHK-2020/09
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 15, 2020
Est. completion date January 1, 2031

Study information
Verified date October 2020
Source Deutsches Herzzentrum Muenchen
Contact Patrick Mayr, MD
Phone +498912180
Email mayrp@dhm.mhn.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Description:

Long-term mortality after transcatheter mitral or tricuspid valve therapy

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date January 1, 2031
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria:

- Age above 18 years and consentable

- Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis

- Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision

- Written informed consent

Exclusion Criteria:

- Patient's inability to fully cooperate with the protocol

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• edge-to-edge valve repair
edge-to-edge valve repair

Locations
Country Name City State
Germany Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München Munich Bavaria

Sponsors (1)
Lead Sponsor Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term mortality Long-term mortality 5 years
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