Clinical trial NCT04522154: Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
Official title: Transcatheter Tricuspid Valve Interventions and Right Ventricular Function: Evaluation with Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tricuspid Valve Insufficiency
Lead sponsor: Heart and Diabetes Center North-Rhine Westfalia
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Influence of transcatheter tricuspid intervention on tricuspid annular plane systolic excursion resonance tomography and echocardiography
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on right ventricular basal diameter excursion in resonance tomography and echocardiography
timeFrame: 3 Month
measure: Influence of transcatheter tricuspid intervention on right ventricular stroke volume resonance tomography and echocardiography
timeFrame: 3 Month
measure: Influence of transcatheter tricuspid intervention on right ventricular ejection fraction resonance tomography and echocardiography
timeFrame: 3 Month
measure: Influence of transcatheter tricuspid intervention on right ventricular global longitudinal strain resonance tomography and echocardiography
timeFrame: 3 Month
measure: Influence of transcatheter tricuspid intervention on right ventricular fractional area change resonance tomography and echocardiography
timeFrame: 3 Month
measure: Influence of transcatheter tricuspid intervention on tricuspid regurgitant fraction resonance tomography and echocardiography
timeFrame: 3 Month
Secondary outcomes:
measure: Exercise Testing with 6 min walking test
timeFrame: 3 month
measure: rehospitalization rate
timeFrame: 3 month
measure: Stroke
timeFrame: 3 month
measure: Death due to cardiovascular complication
timeFrame: 3 month
measure: Influence of transcatheter tricuspid intervention on the cardiopulmonary exercise capacity
timeFrame: 3 month
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum, NRW
state: NRW
Study officials:
affiliation: Assistant physician
name: Muhammed Gercek, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: