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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Tricuspid Regurgitation (TR)

Treatments: Diagnostic Test: 14 days ambulatory rhythm monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT07043465

S68180

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

14 days ambulatory rhtyhm monitoring

Experimental group

Description:

14 days ambulatory rhtyhm monitoring to detect electrical instability

Treatment:

Diagnostic Test: 14 days ambulatory rhythm monitoring