An interventional study of Smartphone-based PPG monitoring in Atrial Fibrillation (AF), sponsored by Ziekenhuis Oost-Limburg. Not yet recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Ziekenhuis Oost-Limburg · Not applicable, Interventional, and Health services research
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 200 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Ziekenhuis Oost-Limburg is the lead sponsor of 69 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Twice daily smartphone based PPG assessment of current heart rhythm in the 7 days before planned electrical cardioversion.
Device: Smartphone-based PPG monitoring
No additional remote monitoring before planned electrical cardioversion.
Twice daily smartphone-based PPG monitoring during 7 days before planned admission for electrical cardioversion
Cancellation of planned admission for electrical cardioversion.
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.
Spontaneous reconversion rate
Defined as the rate of patients having at least one ECG measurement in sinus rhythm before planned cardioversion.
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.
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
AF or Aflutter recurrence rate during 30 days post-cardioversion
Time frame: from planned admission until 30 days afterwards
AF or Aflutter recurrence rate during 1 year follow-up.
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 to AF or Aflutter recurrence.
Time frame: From planned admission until 1 year of follow up
Electrical cardioversion rate during 1 year 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
The AI-enabled ECG-derived atrial fibrillation risk score will be calculated from a standard 12-lead ECG recorded in sinus rhythm. The score ranges from 0 to 100, with higher scores indicating a higher estimated risk of atrial fibrillation. Recurrence will be defined as documented atrial fibrillation or atrial flutter occurring after the planned admission date. Cox proportional-hazards regression will be used to estimate the hazard ratio for time to first AF or atrial flutter recurrence per 10-point increase in the AI-derived 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
The AI-enabled ECG-derived atrial fibrillation risk score will be calculated from the most recent standard 12-lead ECG recorded in sinus rhythm. The score ranges from 0 to 100, with higher scores indicating a higher estimated risk of atrial fibrillation. Spontaneous reconversion will be defined as documented restoration of sinus rhythm before the planned admission for electrical cardioversion. Logistic regression will be used to estimate the odds ratio for spontaneous reconversion per 10-point increase in the AI-derived 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.
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.
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.
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
The accuracy of smartphone-based PPG monitoring in detecting spontaneous reconversion of AF in patients planned for electrical cardioversion will be evaluated by calculating key performance metrics such as sensitivity, specificity, positive predictive value, and negative predictive value. For each participant all AF, Aflutter and sinus rhythm episodes identified by the PPG system automatic algorithm, as well as blinded cardiologist's interpretation will be compared against those recorded by a simultaneous single lead or 12 lead ECG. The concordance between these methods, as determined by two independent, blinded cardiologists will assess the PPG system's ability to accurately classify AF, Aflutter and sinus rhythm events.
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Paroxysmal AF detection rate
Defined as the rate of patients having at least one ECG measurement in AF/Aflutter after experiencing spontaneous reconversion during the monitoring period.
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Missed AF or Aflutter event rate using PPG monitoring.
This will be reported as the amount of simultaneous AF/AFlutter ECG and sinus rhythm PPG recording pairs divided by the total AF/AFlutter ECG recordings.
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Other arrhythmia detected by single lead ECG.
The rates of each arrhythmia will be reported.
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Conversion rate to other type of atrial arrhythmia (Atrial tachycardia, atrial flutter or AF).
This will be defined as the rate of patients having at least one ECG measurement showing a different atrial arrhythmia than the atrial arrhythmia at inclusion during the monitoring period.
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Mean absolute difference between PPG-derived and ECG-derived heart rate
Heart rate will be measured simultaneously using smartphone photoplethysmography and a single-lead ECG. For each paired measurement, the absolute difference between the heart rate reported by the PPG measurement and the heart rate reported by the ECG measurement will be calculated as: Absolute heart-rate difference = PPG heart rate - ECG heart rate The mean absolute difference across all evaluable paired measurements will be reported.
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Symptom rate during rhythm assessments.
This will be reported as the percentage of measurements where symptoms have been indicated, the percentage of measurements where no symptoms have been indicated, the percentage of AF/Aflutter measurements where
Time frame: From enrolment until 30 days after planned admission.
Correlation analysis of clinical parameters and symptomatic AF/Aflutter recording rate as well as the SRC index.
Correlation analysis of clinical parameters and symptomatic AF/Aflutter recording rate as well as the SRC index.
Time frame: From enrolment until 30 days after planned admission.
Weekly alcohol consumption
Self-reported alcohol consumption will be assessed using a study-specific questionnaire at baseline, on admission for electrical cardioversion, and at the 30-day follow-up. At each assessment, participants will report the number of standard alcoholic units consumed during a typical week. One standard alcoholic unit will be defined as (one glass of wine, one beer, or one shot/measure of spirits). Alcohol consumption will subsequently be compared between participants with and without documented recurrence of atrial fibrillation or atrial flutter within one year.
Time frame: From enrollment until one year follow up after planned admission. Recurrence status assessed through one year
Number of days with alcohol consumption per week
The frequency of alcohol consumption will be assessed using a study-specific questionnaire at baseline, on admission for electrical cardioversion, and at the 30-day follow-up. At each assessment, participants will report the number of days during a typical week on which they consume alcohol. Alcohol-consumption frequency will subsequently be compared between participants with and without documented recurrence of atrial fibrillation or atrial flutter within one year.
Time frame: From enrolment until 30 days of follow-up. Recurrence status assessed through one year.
Weekly caffeine consumption
Self-reported caffeine consumption will be assessed using a study-specific questionnaire at baseline, on admission for electrical cardioversion, and at the 30-day follow-up. At each assessment, participants will report their consumption of caffeinated beverages during a typical week. A caffeinated beverage will be defined as a cup of coffee (one standard cup/mug of caffeinated coffee) or a caffeinated drink other than coffee (one cup/glass/can/bottle of tea, cola, energy drink, etc). Caffeine consumption will subsequently be compared between participants with and without documented recurrence of atrial fibrillation or atrial flutter within one year.
Time frame: From enrolment until 30-days of follow up. Recurrence status assessed through one year.
Number of days with caffeine consumption per week
The frequency of caffeine consumption will be assessed using a study-specific questionnaire at baseline, on admission for electrical cardioversion, and at the 30-day follow-up. At each assessment, participants will report the number of days during a typical week on which they consume caffeinated beverages. Caffeine-consumption frequency will subsequently be compared between participants with and without documented recurrence of atrial fibrillation or atrial flutter within one year.
Time frame: From enrolment until 30-days of follow up. Recurrence status assessed through one year.
Odds ratio for spontaneous reconversion per additional weekly alcohol unit at enrollment
Alcohol consumption will be assessed at enrollment using a study-specific questionnaire. Participants will report the number of standard alcoholic units consumed during a typical week. One standard alcoholic unit will be defined as (one glass of wine, one beer, or one shot/measure of spirits). Spontaneous reconversion will be defined as documented restoration of sinus rhythm before the planned admission for electrical cardioversion. Logistic regression will be used to estimate the odds ratio for spontaneous reconversion per additional alcoholic unit consumed per week.
Time frame: Alcohol consumption assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Odds ratio for spontaneous reconversion per additional day of alcohol consumption per week at enrollment
Frequency of alcohol consumption will be assessed at enrollment using a study-specific questionnaire. Participants will report the number of days during a typical week on which they consume alcohol. Spontaneous reconversion will be defined as documented restoration of sinus rhythm before the planned admission for electrical cardioversion. Logistic regression will be used to estimate the odds ratio for spontaneous reconversion per additional day of alcohol consumption per week.
Time frame: Alcohol consumption frequency assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Odds ratio for spontaneous reconversion per additional weekly caffeine serving at enrollment
Caffeine consumption will be assessed at enrollment using a study-specific questionnaire. Participants will report the number of standard servings of caffeinated beverages consumed during a typical week. A caffeinated beverage will be defined as a cup of coffee (one standard cup/mug of caffeinated coffee) or a caffeinated drink other than coffee (one cup/glass/can/bottle of tea, cola, energy drink, etc). Spontaneous reconversion will be defined as documented restoration of sinus rhythm before the planned admission for electrical cardioversion. Logistic regression will be used to estimate the odds ratio for spontaneous reconversion per additional caffeinated serving consumed per week.
Time frame: Caffeine consumption assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Odds ratio for spontaneous reconversion per additional day of caffeine consumption per week at enrollment
Frequency of caffeine consumption will be assessed at enrollment using a study-specific questionnaire. Participants will report the number of days during a typical week on which they consume caffeinated beverages. Spontaneous reconversion will be defined as documented restoration of sinus rhythm before the planned admission for electrical cardioversion. Logistic regression will be used to estimate the odds ratio for spontaneous reconversion per additional day of caffeinated beverage consumption per week.
Time frame: Caffeinated beverage consumption frequency assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Patient adherence with self-monitoring.
Adherence to smartphone-based self-monitoring will be calculated for each participant as the number of completed scheduled recordings divided by the total number of scheduled recordings during the prescription period, multiplied by 100. The mean or median participant-level adherence percentage will be reported.
Time frame: From enrolment until 30 days after planned admission
Patient motivation with self-monitoring.
Motivation will be calculated for each participant as the number of prescribed monitoring days on which at least two scheduled recordings were completed divided by the total number of prescribed monitoring days, multiplied by 100. The mean or median participant-level percentage of adherent monitoring days will be reported.
Time frame: From enrolment until 30 days after planned admission.
Rescheduled electrical cardioversion rate after initial cancellation
Rescheduled electrical cardioversion rate after initial cancellation
Time frame: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Plan to share: Yes — individual participant data will be shared upon reasonable request to the principle investigator.
Supporting information: Study protocol, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 796 non-industry interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 11 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Ziekenhuis Oost-Limburg