DIGITal mOnitoring afTer Af abLation

NCT05486364 | Completed

• 1 other identifier: Z-2021058
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Atrial Fibrillation Recurrent; PVI

Keywords

Atrial Fibrillation; PVI; Atrial ablation; pulmonary vein isolation; PPG; Photoplethysmography; Digital Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.

  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

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

  1 year

• Predictive value of AF detection with PPG during blanking period for AF recurrence.

  1 year

Other Outcomes (3)

• Patient compliance with PPG measurements

  1 year

• Evaluation of AF-burden quantification by intermittent PPG measurements.

  1 year

• Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3

  1 year

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

Digital Monitoring DIAGNOSTIC_TEST

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.

Study group

Standard of care DIAGNOSTIC_TEST

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).

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 3, 2022
• Study Start: December 20, 2021
• Primary Completion: July 1, 2023
• Study Completion: August 15, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

BE (1)