Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation

Official title

Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation: a Randomized Controlled Trial

Overview

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.

Interventions

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

Primary outcome measures

• 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.]

Secondary outcome measures (12)

• Spontaneous reconversion rate [Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.]
• Cost analysis of systematic PPG monitoring prior to cardioversion. [Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.]
• AF or Aflutter recurrence rate post-cardioversion [Time frame: from planned admission until 30 days afterwards]
• AF or Aflutter recurrence rate during 1 year follow-up. [Time frame: From planned admission until 1 year of follow-up.]
• Time to AF or Aflutter recurrence. [Time frame: From planned admission until 1 year of follow up]
• Electrical cardioversion rate during 1 year follow-up. [Time frame: From planned admission until 1 year of follow-up.]
• Hazard ratio for AF or atrial flutter recurrence per 10-point increase in the AI-enabled ECG-derived AF risk score [Time frame: AI-ECG score assessed using the prespecified sinus-rhythm ECG. Recurrence assessed through one year after planned admission]
• Odds ratio for spontaneous reconversion per 10-point increase in the AI-enabled ECG-derived AF risk score [Time frame: AI-ECG score assessed using the last available sinus-rhythm ECG before date of randomization. Spontaneous cardioversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.]
• Prediction analysis for spontaneous conversion to sinus rhythm before admission. [Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.]
• Prediction analysis for AF/Aflutter recurrence during one year follow-up. [Time frame: From enrollment until one year of follow-up after planned admission.]
• Patient-reported AFEQT overall score and domain scores at baseline and 30-day follow-up. [Time frame: From enrollment until 30 days of follow-up after planned admission.]
• The accuracy of smartphone-based PPG monitoring in detecting spontaneous reconversion of AF in patients planned for electrical cardioversion [Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Belgium · 2 centers

• Ziekenhuis Oost Limburg — Genk
• University Hospitals Leuven — Leuven

Identifiers

NCT: NCT07752940 · Z-2025056

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗