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

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tricuspid Regurgitation (TR)

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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14 days ambulatory rhtyhm monitoring

14 days ambulatory rhtyhm monitoring to detect electrical instability

Group Type EXPERIMENTAL

14 days ambulatory rhythm monitoring

Intervention Type DIAGNOSTIC_TEST

14 days ambulatory rhythm monitoring using Byteflies

Interventions

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14 days ambulatory rhythm monitoring

14 days ambulatory rhythm monitoring using Byteflies

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Tricuspid valve regurgitation (TVR) grade ≥3/4 documented on Colour Doppler during routine transthoracic echocardiography
* Normal sinus rhythm
* Dutch speaking