NCT04577248

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2020Jan 2031

Study Start

First participant enrolled

September 15, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

10.3 years

First QC Date

October 1, 2020

Last Update Submit

October 6, 2020

Conditions

Mitral Valve RegurgitationMitral Valve StenosisTricuspid Valve Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Long-term mortality

    Long-term mortality

    5 years

Interventions

edge-to-edge valve repairDEVICE

edge-to-edge valve repair

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patient's inability to fully cooperate with the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München

Munich, Bavaria, D80636, Germany

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve StenosisTricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Patrick Mayr, MD

    Dept. of Anesthesiology, Deutsches Herzzentrum München

    STUDY CHAIR

  • Michael Joner, Prof

    Dept. of Cardiology, Deutsches Herzzentrum München

    STUDY CHAIR

  • Tobias Rheude, MD

    Dept. of Cardiology, Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

  • Costanza Pellegrini, MD

    Dept. of Cardiology, Deutsches Herzzentrum München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Mayr, MD

CONTACT

+498912180mayrp@dhm.mhn.de

Joner Michael, Prof

CONTACT

+498912180joner@dhm.mhn.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 6, 2020

Study Start

September 15, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

January 1, 2031

Last Updated

October 8, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)