An interventional study of Digital Monitoring and Standard of care in Atrial Fibrillation, Atrial Fibrillation Recurrent and PVI, sponsored by Ziekenhuis Oost-Limburg. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Diagnostic
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 100 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ziekenhuis Oost-Limburg is the lead sponsor of 66 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Diagnostic Test: Standard of care
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.
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).
AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
Time frame: 1 year
Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.
Time frame: 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.
Time frame: 1 year
Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.
Time frame: 1 year
Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.
Time frame: 1 year
Predictive value of AF detection with PPG during blanking period for AF recurrence.
Time frame: 1 year
Patient compliance with PPG measurements
Time frame: 1 year
Evaluation of AF-burden quantification by intermittent PPG measurements.
Time frame: 1 year
Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3
Excluding ECG measurements that were triggered by AF detection with PPG.
Time frame: 1 year
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Oost-Limburg