Actively Recruiting

Age: 18Years - 110Years
All Genders
ID04577248

The Prospective Observational Munich Interventional Mitral-Valve Registry

Led by Deutsches Herzzentrum Muenchen · Updated on 2020-10-08

5000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to observe and collect data on patients undergoing transcatheter mitral or tricuspid valve therapy at a single center in Germany. It focuses on long-term outcomes, particularly mortality over a 5-year period, for individuals with mitral valve regurgitation, mitral valve stenosis, or tricuspid valve regurgitation. The study is observational, meaning it monitors patients receiving care without assigning specific treatments. Participants receive edge-to-edge valve repair as part of their transcatheter valve therapy, which is determined by a heart-team decision to be the best option for their condition. This device-based treatment will be tracked over time as part of the registry. The study started in September 2020 and will continue through January 2031, allowing for long-term follow-up. During the study, researchers will monitor patients' health and survival for up to five years after their valve therapy. Data collected will include mortality outcomes and other health information, without altering standard care. Participants provide informed consent and will be followed through regular medical assessments to contribute to understanding the therapy's long-term effects.

CONDITIONS

Brief Title

The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age above 18 years and consentable
  • Diagnosis of mitral valve regurgitation, mitral valve stenosis, tricuspid valve regurgitation, or tricuspid stenosis
  • Transcatheter mitral or tricuspid valve therapy recommended as best option by heart-team decision
  • Ability to provide written informed consent
Not Eligible

You will not qualify if you...

  • Inability to fully cooperate with the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo edge-to-edge valve repair as part of their treatment.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are followed to assess long-term outcomes after valve repair.

Regular visits scheduled according to routine clinical care

Trial Site Locations

Total: 1 location

1

Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München

Munich, Bavaria, Germany, D80636

Actively Recruiting

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Research Team

P

Patrick Mayr, MD

J

Joner Michael, Prof

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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