Atrial Fibrillation (AF)SPARE-AFNCT07752940
Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation
A study testing Smartphone-based PPG monitoring in people with Atrial Fibrillation (AF), run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Smartphone-based PPG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Aug 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laurent Pison, MD, PhD contact
Belgium2 sites
Ziekenhuis Oost Limburg
Genk, Limburg, 3600
Michiel De Wever, MD, +32470059144, michiel.dewever@zol.be
Laurent Pison, MD, PhD, laurent.pison@zol.be
University Hospitals Leuven
Leuven, Vlaams-Brabant, 3000
Michiel De Wever, MD, +32470059144, michiel.dewever@uzleuven.be
Peter Haemers, MD, PhD, peter.haemers@uzleuven.be
About this study
Official title: Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation: a Randomized Controlled Trial
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)
- Being tested
- Smartphone-based PPG monitoring
- Keywords
- electrical cardioversion, photoplethysmography, Remote monitoring, persistent af, RCT
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based PPG monitoringDevice
Twice daily smartphone-based PPG monitoring during 7 days before planned admission for electrical cardioversion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smartphone-based PPG monitoring |
| Control arm | No intervention | No additional remote monitoring before planned electrical cardioversion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancellation of planned admission for electrical cardioversion.
Cancellation of planned admission for electrical cardioversion.
Measured: 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
Defined as the rate of patients having at least one ECG measurement in sinus rhythm before planned cardioversion.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From planned admission until 1 year of follow-up.
Time to AF or Aflutter recurrence.
Time to AF or Aflutter recurrence.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrolment until 30 days after planned admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Oost-Limburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Sponsor
- Investigators
- Laurent Pison, Principal investigator, Ziekenhuis Oost-LimburgPeter Haemers, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07752940
- Sponsor's protocol ID
- Z-2025056
- Acronym
- SPARE-AF
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: individual participant data will be shared upon reasonable request to the principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07752940
- Acronym / sponsor ID
- SPARE-AF / Z-2025056
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- electrical cardioversion, photoplethysmography, Remote monitoring, persistent af, RCT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ziekenhuis Oost-LimburgUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (PPG-based monitoring) | Active comparator | Device: Smartphone-based PPG monitoringTwice daily smartphone based PPG assessment of current heart rhythm in the 7 days before planned electrical cardioversion. |
| Control arm | No intervention | –No additional remote monitoring before planned electrical cardioversion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based PPG monitoringTwice daily smartphone-based PPG monitoring during 7 days before planned admission for electrical cardioversion | Device | Intervention arm (PPG-based monitoring) |
Primary outcome
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.
Cancellation of planned admission for electrical cardioversion.
29 secondary outcomes
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.
Paroxysmal AF detection rate
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.
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.
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).
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
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.
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.
Time frame: From enrolment until 30 days after planned admission.
Weekly alcohol consumption
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
Time frame: From enrolment until 30 days of follow-up. Recurrence status assessed through one year.
Weekly caffeine consumption
Time frame: From enrolment until 30-days of follow up. Recurrence status assessed through one year.
Number of days with caffeine consumption per week
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
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
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
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
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.
Time frame: From enrolment until 30 days after planned admission
Patient motivation with self-monitoring.
Time frame: From enrolment until 30 days after planned admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. individual participant data will be shared upon reasonable request to the principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Pison, MD, PhD contact
Laurent Pison principal investigator
Ziekenhuis Oost-Limburg
Peter Haemers principal investigator
Universitaire Ziekenhuizen KU Leuven
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based PPG monitoring in people with Atrial Fibrillation (AF), run by Ziekenhuis Oost-Limburg at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michiel De Wever, MD (+32470059144, michiel.dewever@zol.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.