Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation

NCT07752940 | Not Yet Recruiting DMC

• 1 other identifier: Z-2025056
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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)

Keywords

electrical cardioversion; photoplethysmography; Remote monitoring; persistent af; RCT

Outcome Measures

Primary Outcomes (1)

• Cancellation of planned admission for electrical cardioversion.

  Cancellation of planned admission for electrical cardioversion.

  From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.

Secondary Outcomes (29)

• Spontaneous reconversion rate

  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.

  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

  from planned admission until 30 days afterwards

• AF or Aflutter recurrence rate during 1 year follow-up.

  From planned admission until 1 year of follow-up.

• Time to AF or Aflutter recurrence.

  From planned admission until 1 year of follow up

Other Outcomes (1)

• Rescheduled electrical cardioversion rate after initial cancellation

  From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.

Study Arms (2)

Intervention arm (PPG-based monitoring)

ACTIVE COMPARATOR

Twice daily smartphone based PPG assessment of current heart rhythm in the 7 days before planned electrical cardioversion.

Device: Smartphone-based PPG monitoring

Control arm

NO INTERVENTION

No additional remote monitoring before planned electrical cardioversion.

Interventions

Smartphone-based PPG monitoring DEVICE

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

Intervention arm (PPG-based monitoring)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziekenhuis Oost-Limburg: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (2)

Ziekenhuis Oost Limburg

Genk, Limburg, 3600, Belgium

Location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Laurent Pison

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

• Peter Haemers

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michiel De Wever, MD

CONTACT

+32470059144; michiel.dewever@zol.be

Laurent Pison, MD, PhD

CONTACT

Laurent.pison@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 1 year after publication with no end date
• Access Criteria: individual participant data will be shared upon reasonable request to the principle investigator.

Locations

BE (2)