The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry (OBSERV-MITRA)

October 6, 2020 updated by: Deutsches Herzzentrum Muenchen
Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Long-term mortality after transcatheter mitral or tricuspid valve therapy

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, D80636
        • Recruiting
        • Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München
        • Principal Investigator:
          • Patrick Mayr, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 110 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All-comers patient population treated with transcatheter mitral or tricuspid valve therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term mortality
Time Frame: 5 years
Long-term mortality
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2020

Primary Completion (ANTICIPATED)

December 31, 2030

Study Completion (ANTICIPATED)

January 1, 2031

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 1, 2020

First Posted (ACTUAL)

October 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE DHM-AN-EHK-2020/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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