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

Tricuspid Valve Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522154
• Other study ID #: HDZ-KA_017_MG
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: Muhammed Gercek, Dr. med
• Phone: 0049571971258
• Email: mugercek[@]hdz-nrw.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Valve Insufficiency

Intervention

Diagnostic Test:
• Magnet resonance imaging
Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum, NRW	Bad Oeynhausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Exercise Testing with 6 min walking test	Changes on walked distance after transcatheter tricuspid intervention	3 month
Secondary	rehospitalization rate	Detection of rehospitalization rate after transcatheter tricuspid intervention	3 month
Secondary	Stroke	Detection of stroke rate after transcatheter tricuspid intervention	3 month
Secondary	Death due to cardiovascular complication	Detection of death rate due to cardiovascular complications after transcatheter tricuspid intervention	3 month
Secondary	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