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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14 days ambulatory rhtyhm monitoring | Experimental | 14 days ambulatory rhtyhm monitoring to detect electrical instability |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14 days ambulatory rhythm monitoring | Diagnostic Test | 14 days ambulatory rhythm monitoring using Byteflies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Belgium | 3000 | Belgium |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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,...) |
| 14 days |