DIGITal mOnitoring afTer Af abLation

Atrial Fibrillation Clinical Trial

— DIGITOTAL  

Official title:

A Study of Intermittent Photoplethysmography Based Rhythm Monitoring for Detection of Atrial Fibrillation Recurrence After Pulmonary Vein Isolation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486364
• Other study ID #: Z-2021058
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2023
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 15, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Recurrent
• PVI

Intervention

Diagnostic Test:
• Digital 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.
• Standard 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).

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient compliance with PPG measurements		1 year
Other	Evaluation of AF-burden quantification by intermittent PPG measurements.		1 year
Other	Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3	Excluding ECG measurements that were triggered by AF detection with PPG.	1 year
Primary	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	Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.		1 year
Secondary	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
Secondary	Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.		1 year
Secondary	Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.		1 year
Secondary	Predictive value of AF detection with PPG during blanking period for AF recurrence.		1 year