DIGITal mOnitoring afTer Af abLation (DIGITOTAL)

October 24, 2023 updated by: Laurent Pison, Ziekenhuis Oost-Limburg

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Genk, Belgium, 3600
        • Ziekenhuis Oost-Limburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
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.
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AF detection rate with PPG-monitoring vs standard of care monitoring after the blanking period in the first-year post AF ablation
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to detection of AF after PVI (and after the blanking period) with PPG monitoring vs standard of care monitoring.
Time Frame: 1 year
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.
Time Frame: 1 year
1 year
Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.
Time Frame: 1 year
1 year
Proportion of confirmed symptom-rhythm correlations by PPG-monitoring vs standard care monitoring in patients who report symptoms on outpatient consultations.
Time Frame: 1 year
1 year
Predictive value of AF detection with PPG during blanking period for AF recurrence.
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient compliance with PPG measurements
Time Frame: 1 year
1 year
Evaluation of AF-burden quantification by intermittent PPG measurements.
Time Frame: 1 year
1 year
Subanalysis of primary outcome 1 and secondary outcomes 1,2 and 3
Time Frame: 1 year
Excluding ECG measurements that were triggered by AF detection with PPG.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

August 15, 2023

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 2, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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