Atrial Fibrillation, Atrial Fibrillation Recurrent, PVI
Conditions
Keywords
Atrial Fibrillation, PVI, Atrial ablation, pulmonary vein isolation, PPG, Photoplethysmography, Digital Health
Brief summary
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.
Interventions
DIAGNOSTIC_TESTDigital Monitoring
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.
DIAGNOSTIC_TESTStandard of care
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).
Sponsors
Ziekenhuis Oost-Limburg
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
* 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring. | 1 year |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient compliance with PPG measurements | 1 year | — |
| Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3 | 1 year | Excluding ECG measurements that were triggered by AF detection with PPG. |
| Evaluation of AF-burden quantification by intermittent PPG measurements. | 1 year | — |
Countries
Belgium
Outcome results
None listed