Clinical trial NCT05486364: DIGITal mOnitoring afTer Af abLation
Official title: A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation Recurrent
PVI
Keywords: Atrial Fibrillation
PVI
Atrial ablation
pulmonary vein isolation
PPG
Photoplethysmography
Digital Health
Lead sponsor: Ziekenhuis Oost-Limburg
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
timeFrame: 1 year
Secondary outcomes:
measure: Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.
timeFrame: 1 year
measure: The number and dispersion of PPG measurements needed to achieve similar sensitivity with intermittent one-minute PPG measurements compared to one 24h-Holter.
timeFrame: 1 year
measure: Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.
timeFrame: 1 year
measure: Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.
timeFrame: 1 year
measure: Predictive value of AF detection with PPG during blanking period for AF recurrence.
timeFrame: 1 year
Other outcomes:
measure: Patient compliance with PPG measurements
timeFrame: 1 year
measure: Evaluation of AF-burden quantification by intermittent PPG measurements.
timeFrame: 1 year
measure: Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3
timeFrame: 1 year
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
Study officials:
References: