Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging

March 10, 2025 updated by: Muhammed Gerçek, Heart and Diabetes Center North-Rhine Westfalia
There is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. Despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. Right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. Therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Germany
    • NRW
      • Bad Oeynhausen, NRW, Germany, 32545
        • Herz- und Diabeteszentrum, NRW

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention.

Exclusion Criteria:

  • Patient with Incompatibility with magnetic resonance imaging or echocardiography
  • Another valve disorder that requires treatment
  • Severe precapillary pulmonary hypertension
  • Unstable angina or percutaneous coronary intervention within the last 30 days
  • Previous pacemaker/defibrillator implantation with intracardiac leads
  • Patients with cardiac cachexia or a life expectancy less then 12 months
  • Allergies to the material used.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MR-TTE
Patient receiving cardiac magnet resonance imaging and echocardiography
Diagnostic test: Magnet resonance imaging
Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
Time Frame: 3 month
Changes on tricuspid annular plane systolic excursion in magnet resonance tomography and echocardiography after of transcatheter tricuspid intervention
3 month
Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
Time Frame: 3 Month
Changes on right ventricular basal diameter in resonance tomography and echocardiography after transcatheter tricuspid intervention
3 Month
Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
Time Frame: 3 Month
Changes on right ventricular stroke volume in resonance tomography and echocardiography after transcatheter tricuspid intervention
3 Month
Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
Time Frame: 3 Month
Changes on right ventricular ejection fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
3 Month
Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
Time Frame: 3 Month
Changes on right ventricular global longitudinal in resonance tomography and echocardiography after transcatheter tricuspid intervention
3 Month
Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
Time Frame: 3 Month
Changes on right ventricular fractional area change in resonance tomography and echocardiography after transcatheter tricuspid intervention
3 Month
Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
Time Frame: 3 Month
Changes on tricuspid regurgitant fraction in resonance tomography and echocardiography after transcatheter tricuspid intervention
3 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Testing with 6 min walking test
Time Frame: 3 month
Changes on walked distance after transcatheter tricuspid intervention
3 month
rehospitalization rate
Time Frame: 3 month
Detection of rehospitalization rate after transcatheter tricuspid intervention
3 month
Stroke
Time Frame: 3 month
Detection of stroke rate after transcatheter tricuspid intervention
3 month
Death due to cardiovascular complication
Time Frame: 3 month
Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention
3 month
Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity
Time Frame: 3 month
Changes on aerobic capacity and endurance using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram)
3 month

Collaborators and Investigators

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

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Investigators

  • Principal Investigator: Muhammed Gercek, Dr. med., Assistant physician

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)

August 1, 2020

Primary Completion (Actual)

March 9, 2025

Study Completion (Actual)

March 9, 2025

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDZ-KA_017_MG

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

product manufactured in and exported from the U.S.

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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