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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Monitoring | Diagnostic Test | 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. |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient compliance with PPG measurements | 1 year | |
| Evaluation of AF-burden quantification by intermittent PPG measurements. | 1 year | |
| Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | 3600 | Belgium |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| Standard of care | Diagnostic Test | 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). |
|
| 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 |
Excluding ECG measurements that were triggered by AF detection with PPG. |
| 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |