Tricuspid Regurgitation (TR)
Conditions
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.
Interventions
DIAGNOSTIC_TEST14 days ambulatory rhythm monitoring
14 days ambulatory rhythm monitoring using Byteflies
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial electrical instability | 14 days | 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. |
| Ventricular electrical instability | 14 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bradycardia | 14 days | 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. |
| Adverse events associated with rhythm monitoring | 14 days | Prevalence (%) of any interruption in 14 days rhythm monitoring due to adverse events with the Byteflies monitoring patch (skin rash, allergic reactions,...) |
Countries
Belgium
Outcome results
None listed