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Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation

NCT07752940 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-07

No results posted yet for this study

Summary

This study investigates whether a smartphone application that measures heart rhythm using light, a technique known as photoplethysmography or PPG, can accurately detect when the cardiac arrhythmia atrial fibrillation (AF) spontaneously terminates and the heart returns to normal sinus rhythm. This is a prospective, multicentre randomised controlled study conducted at Hospital East Limburg and University Hospitals Leuven.

Continuous heart rhythm monitoring with conventional equipment is often not feasible in the home setting because of the high cost and complexity of the equipment. Smartphone-based PPG monitoring offers a practical and affordable alternative. The study will include 200 adult patients with known AF who are scheduled for elective electrical cardioversion. Patient will be randomised to either standard of care (no remote monitoring) or smartphone-based PPG monitoring. During the seven days preceding the procedure, participants in the intervention group will perform PPG and ECG measurements at predefined times using their smartphone and a chest strap.

The primary objective is to determine whether this intermittent, app-guided monitoring can detect spontaneous conversion to normal sinus rhythm before the planned cardioversion, thereby preventing unnecessary hospital admissions. In addition, we will evaluate the relationship between symptoms and cardiac rhythm, adherence to and user experience with self-monitoring, and the predictive value of the measured parameters for recurrence of AF or atrial flutter during one year of follow-up.

Conditions

  • Atrial Fibrillation (AF)

Interventions

DEVICE

Smartphone-based PPG monitoring

Twice daily smartphone-based PPG monitoring during 7 days before planned admission for electrical cardioversion

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    collaborator OTHER

  • Ziekenhuis Oost-Limburg

    lead OTHER

Principal Investigators

  • Laurent Pison · Ziekenhuis Oost-Limburg

  • Peter Haemers · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-31
Completion
2028-07-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07752940 on ClinicalTrials.gov