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NCT07752940
Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation
Conditions: Atrial Fibrillation (AF)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Ziekenhuis Oost-Limburg
Location: Ziekenhuis Oost Limburg Genk Limburg
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.
Eligibility Criteria
Inclusion Criteria:
* Provide signed and dated informed consent
* Males or females aged ≥ 18 years
* Diagnosis of atrial fibrillation based on ECG in medical history
* Patient in atrial fibrillation when planned for electrical cardioversion as evidenced by an ECG
* In possession of a smartphone
* Being able and having the time to perform heart rhythm measurement using the FibriCheck application at home
Exclusion Criteria:
* Cardiac implantable devices such as pacemakers, CRT's or ICD's.
* No access to a smartphone or unable to perform PPG measurements independently.
* Active follow-up in Fibricheck care pathways
Source: ClinicalTrials.gov (NCT07752940). StuddyBuddy aggregates publicly available trial information.