Ambulant Monitoring to Detect Hemodynamic and Electrical Impact of Severe Tricuspid Valve Regurgitation

Universitaire Ziekenhuizen KU Leuven20 enrolled

Overview

This exploratory study aims to study the feasibility to detect early signs of disease progression in patients with severe TVR (grade ≥3/4) by monitoring electrical cardiac activity and correlating it with echocardiographic findings. The Byteflies monitoring device will be used for continuous 14-day outpatient ECG tracking. Transthoracic echocardiography will assess structural and pressure changes in the heart and liver. The goal is to improve early detection of right heart failure and hepatic congestion.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Tricuspid Regurgitation (TR)

Interventions

14 days ambulatory rhythm monitoringDIAGNOSTIC_TEST

14 days ambulatory rhythm monitoring using Byteflies

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Tricuspid valve regurgitation (TVR) grade ≥3/4 documented on Colour Doppler during routine transthoracic echocardiography * Normal sinus rhythm * Dutch speaking Exclusion Criteria: * History of cardiac surgery * Abnormal rhythm at baseline visit * Age \<18 years

Locations (1)

UZ Leuven

Leuven, Belgium, Belgium

Outcomes

Primary Outcomes

Atrial electrical instability

Burden (expressed in % of total number of beats) of isolated atrial extrasystoles, runs of atrial tachycardie (less than 30 seconds), and sustained atrial arrhythmia (lasting 30 seconds or longer). These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.

Time frame: 14 days

Ventricular electrical instability

Burden (expressed in % of total number of beats) of isolated ventricular extrasystoles, runs of ventricular tachycardie (less than 30 seconds), and sustained ventricular arrhythmia (lasting 30 seconds or longer). These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.

Time frame: 14 days

Secondary Outcomes

Bradycardia

Prevalence (%) of bradycardia events on 14 day rhythm monitoring defined as any occurence of ventricular rhythms \<30 beats per minute or high-degree AV block. These findings will be correlated with echocardopgrahic measurements to detect electrical markers associated with the severity of tricuspid valve regurgitation.

Time frame: 14 days

Adverse events associated with rhythm monitoring

Prevalence (%) of any interruption in 14 days rhythm monitoring due to adverse events with the Byteflies monitoring patch (skin rash, allergic reactions,...)

Time frame: 14 days

Data from ClinicalTrials.gov

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