DIGITal mOnitoring afTer Af abLation

Not Applicable

Completed

• Conditions: PVI; Atrial Fibrillation; Atrial Fibrillation Recurrent
• Interventions: Diagnostic Test: Digital Monitoring; Diagnostic Test: Standard of care

• Registration Number: NCT05486364
• Lead Sponsor: Ziekenhuis Oost-Limburg

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-20
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-03
• Primary Completion: 2023-07-01
• Study Completion: 2023-08-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Digital Monitoring	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.
Study group	Standard of care	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.	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
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

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium