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

Not Applicable

Completed

• Conditions: Tricuspid Valve Insufficiency
• Interventions: Diagnostic Test: Magnet resonance imaging

• Registration Number: NCT04522154
• Lead Sponsor: Heart and Diabetes Center North-Rhine Westfalia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Study First Posted: 2020-08-21
• Status Verified: 2024-01
• Primary Completion: 2025-03-09
• Study Completion: 2025-03-09
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MR-TTE	Magnet resonance imaging	Patient receiving cardiac magnet resonance imaging and echocardiography

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Herz- und Diabeteszentrum, NRW; 🇩🇪 Bad Oeynhausen, NRW, Germany