DIGITal mOnitoring afTer Af abLation

Study Overview
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Brief Summary
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Recurrence of atrial fibrillation (AF) after a pulmonary vein isolation (PVI) procedure is frequent. Current follow up with Holter monitoring and electrocardiograms (ECG) during outpatient clinic consultations cover only short time stretches and require hospital visits. Mobile health solutions with rhythm monitoring using photoplethysmography (PPG) technology on a smartphone could extend rhythm monitoring time, while lowering hospital visits and cost. This study aims to compare the performance of a digital health solution using PPG technology on a smartphone versus the current standard of care to monitor for AF recurrence after a PVI procedure.

Official Title
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A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation

Conditions
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Atrial Fibrillation, Atrial Fibrillation Recurrent, PVI

Intervention / Treatment
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* Diagnostic Test: Digital Monitoring
* Diagnostic Test: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is scheduled for an ablation procedure for AF, at least 4 weeks after the inclusion. Subject provides informed consent. Subject understands and agrees to comply with planned study procedures. Subject is able to perform measurements of the heart rhythm using the FibriCheck application at home. Exclusion Criteria: Insufficient cognitive or comprehensive level of Dutch to participate to the trial. No access to a smartphone or unable to perform FibriCheck measurements at home. Pacemaker.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All subjects will receive both standard of care monitoring and digital rhythm monitoring using a PPG based smartphone application for AF recurrence after the PVI procedure. | Diagnostic Test: Digital Monitoring<br>* Subjects will perform self-measurements with a PPG based smartphone application (FibriCheck™) to monitor for AF recurrence after the PVI procedure. One-minute measurements will be performed twice daily starting one month before the PVI procedure and continue up to 12 months after the procedure.<br>Diagnostic Test: Standard of care<br>* Subjects will wear a 24-hour holter monitor at 3, 6 and 12 months after the PVI procedure. Additionally, outpatient cardiology clinic visits are organised at 6 weeks, 3 months and 12 months after the PVI procedure (including a 12-lead ECG and cardiologist consultation).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring. |  | 1 year | 
| The number and dispersion of PPG measurements needed to achieve similar sensitivity with intermittent one-minute PPG measurements compared to one 24h-Holter. |  | 1 year | 
| Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level. |  | 1 year | 
| Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations. |  | 1 year | 
| Predictive value of AF detection with PPG during blanking period for AF recurrence. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, PVI, Atrial ablation, pulmonary vein isolation, PPG, Photoplethysmography, Digital Health