Ambulant Monitoring to Detect Hemodynamic and Electrical Impact of Severe Tricuspid Valve Regurgitation
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFirst Submitted
Initial submission to the registry
June 11, 2025
CompletedFirst Posted
Study publicly available on registry
June 29, 2025
CompletedJune 29, 2025
June 1, 2025
9 months
June 11, 2025
June 20, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
14 days
Secondary Outcomes (2)
Bradycardia
14 days
Adverse events associated with rhythm monitoring
14 days
Study Arms (1)
14 days ambulatory rhtyhm monitoring
EXPERIMENTAL14 days ambulatory rhtyhm monitoring to detect electrical instability
Interventions
14 days ambulatory rhythm monitoring using Byteflies
Eligibility Criteria
You may qualify if:
- Tricuspid valve regurgitation (TVR) grade ≥3/4 documented on Colour Doppler during routine transthoracic echocardiography
- Normal sinus rhythm
- Dutch speaking
You may not qualify if:
- History of cardiac surgery
- Abnormal rhythm at baseline visit
- Age \<18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Belgium, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2025
First Posted
June 29, 2025
Study Start
February 1, 2024
Primary Completion
October 31, 2024
Study Completion
December 31, 2024
Last Updated
June 29, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share