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

Study Overview
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Brief Summary
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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.

Official Title
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Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation With Magnetic Resonance Imaging

Conditions
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Tricuspid Valve Insufficiency

Intervention / Treatment
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* Diagnostic Test: Magnet resonance imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Changes on walked distance after transcatheter tricuspid intervention | 3 month | 
| rehospitalization rate | Detection of rehospitalization rate after transcatheter tricuspid intervention | 3 month | 
| Stroke | Detection of stroke rate after transcatheter tricuspid intervention | 3 month | 
| Death due to cardiovascular complication | Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention | 3 month | 
| Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity | Changes on aerobic capacity and endurance using the cardiopulmonary exercise testing (vO2max in milliliter per minute per kilogram) | 3 month |