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Completed

NCT Number: NCT05486364

DIGITal mOnitoring afTer Af abLation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Recurrent Cardiovascular Diseases Heart Diseases PVI Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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).

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

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

  2. 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

  3. Sensitivity, specificity and accuracy of PPG rhythm monitoring for AF detection during 24h-Holter monitoring on PPG measurement level.

    Time frame: 1 year

  4. 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

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

    Time frame: 1 year

Other outcomes

  1. Patient compliance with PPG measurements

    Time frame: 1 year

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

    Time frame: 1 year

  3. 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.

Sponsors and collaborators

Lead sponsor

Ziekenhuis Oost-Limburg

Other

Registry information

Official study title

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

Acronym: DIGITOTAL

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 3, 2022
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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