OBSERV-MITRA: The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04577248
Collaborator
(none)
5,000
1
123.5
40.5
Study Details
Study Description
Brief Summary
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Long-term mortality after transcatheter mitral or tricuspid valve therapy
Study Design
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
5000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry
Actual Study Start Date
:
Sep 15, 2020
Anticipated Primary Completion Date
:
Dec 31, 2030
Anticipated Study Completion Date
:
Jan 1, 2031
Outcome Measures
Primary Outcome Measures
- Long-term mortality [5 years]
Long-term mortality
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 110 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München | Munich | Bavaria | Germany | D80636 |
Sponsors and Collaborators
- Deutsches Herzzentrum Muenchen
Investigators
- Study Chair: Patrick Mayr, MD, Dept. of Anesthesiology, Deutsches Herzzentrum München
- Study Chair: Michael Joner, Prof, Dept. of Cardiology, Deutsches Herzzentrum München
- Principal Investigator: Tobias Rheude, MD, Dept. of Cardiology, Deutsches Herzzentrum München
- Principal Investigator: Costanza Pellegrini, MD, Dept. of Cardiology, Deutsches Herzzentrum München
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT04577248
Other Study ID Numbers:
- GE DHM-AN-EHK-2020/09
First Posted:
Oct 6, 2020
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: