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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2025-03-09

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.

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Detailed Description

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Conditions

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Tricuspid Valve Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MR-TTE

Patient receiving cardiac magnet resonance imaging and echocardiography

Group Type OTHER

Magnet resonance imaging

Intervention Type DIAGNOSTIC_TEST

Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure

Interventions

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Magnet resonance imaging

Patients will receive a cardiac magnet resonance tomography before and 3-month after the procedure

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No