DIGITal mOnitoring afTer Af abLation (DIGITOTAL)

East Limburg Hospital

Status: Completed

Conditions: Atrial Fibrillation; PVI; Atrial Fibrillation Recurrent

Treatments: Diagnostic Test: Standard of care; Diagnostic Test: Digital Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT05486364

Z-2021058

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Study group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Digital Monitoring

Diagnostic Test: Standard of care