Clinical Trials Logo
  1. Home
  2. Mitral Valve Regurgitation
  3. NCT04577248
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT02520310 - AVJ-514 Japan Trial N/A
Completed NCT02355418 - The Role of Myocardial Fibrosis in Degenerative Mitral Regurgitation
Recruiting NCT03242642 - Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. N/A
Recruiting NCT02961647 - Hemodynamic Stress Test in Severe Mitral Regurgitation (HEMI) N/A
Active, not recruiting NCT02302872 - Treatment of Heart Failure and Associated Functional Mitral Valve Regurgitation N/A
Completed NCT01777815 - Safety and Performance Study of the NeoChord Device N/A
Withdrawn NCT00428103 - Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy N/A
Completed NCT04351984 - Transcatheter Mitral Valvuloplasty Pilot Study
Withdrawn NCT02722551 - CardiAQ-Edwards™ Transcatheter Mitral Valve Replacement (TMVR) Study Phase 1/Phase 2
Active, not recruiting NCT02321514 - Expanded Clinical Study of the Tendyne Mitral Valve System N/A
Recruiting NCT02245763 - STS/ACC TVT Registry Mitral Module
Active, not recruiting NCT01740583 - Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation N/A
Completed NCT00800046 - A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study N/A
Completed NCT00415701 - Effect of Etomidate on Hemodynamics and Adrenocortical Function After Cardiac Surgery Phase 4
Recruiting NCT03908983 - OPtimisation of Surgical Repair for Treating Insufficiency of the MItral Valve - Safety and Effectiveness Evaluation N/A
Recruiting NCT04818502 - Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation
Terminated NCT03285724 - Safety and Performance Study of the Harpoon Mitral Valve Repair System N/A
Recruiting NCT04195984 - Mi-thos® Transcatheter Mitral Valve Replacement Study N/A
Active, not recruiting NCT04281940 - Chordal Repair for Transcatheter Mitral Valve Repair (TMVr) N/A
Completed NCT03104660 - Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR) N/A