Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation

Sponsor
Ziekenhuis Oost-Limburg
Study ID
NCT07752940
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Aug 7, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Intervention arm (PPG-based monitoring)
    Twice daily smartphone based PPG assessment of current heart rhythm in the 7 days before planned electrical cardioversion.
  • No Intervention: Control arm
    No additional remote monitoring before planned electrical cardioversion.

Primary Outcome Measure

Cancellation of planned admission for electrical cardioversion. [ Time Frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks. ]

Central Contacts

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