Atrial Fibrillation (AF)Find-AF2 WatchNCT06832579
SmartWatch-driven AF Detection in Stroke Patients
A study testing Wearable in people with Atrial Fibrillation (AF) and Ischemic Stroke, run by University of Leipzig at 13 sites in Germany.
Trial summary
Unrecognized atrial fibrillation (AF) is a common cause of ischemic stroke. Implantable event monitors (ICM) are the gold standard for continuous heart rhythm monitoring but they have been implemented in very few patients after stroke due to high invasiveness and high costs. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Ischemic Stroke, ECG Monitoring
- What is being tested?
- Wearable
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 13 sitesGermany
- Study dates
- 15 May 2025to 29 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participation in Find-AF 2
- Randomization in the intervention arm of the Find-AF 2 study and presence of an implanted event recorder (Medtronic Reveal LINQTM Insertable Cardiac Monitor)
- Signed informed consent
- All inclusion criteria of the Find-AF 2 study are met (according to protocol version Final 4.0, dated 08.05.2024):
- Recent symptomatic ischemic stroke within the last 30 days (sudden focal neurologic deficit lasting > 24 h consistent with the territory of a cerebral artery) If the neurologic deficit lasted < 24 h a corresponding lesion* on brain imaging is needed.
- Age ≥ 60 years. iii. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symtoms.
- Written informed consent
- Corresponding lesion can be an acute lesion on diffusion-weighted magnetic resonance imaging, native computed tomography (CT) or CT perfusion imaging or a recent occlusion or intracranial thrombus on angiography (CTA, MRA, DSA)
Who cannot join
- Expiration of the battery of the event recorder in <3 months
- No in ICM data transmission possible (e. g. missing compliance)
- Poor ECG data quality according to core lab evaluation (e.g. permanent oversensing), which prevents meaningful evaluation of the event recorder data
- Exclusion criteria of the Find-AF 2 study (according to protocol version Final 4.0, dated 08.05.2024):
- Known history of atrial fibrillation/flutter or atrial fibrillation/flutter on admission ECG.
- Current indication or contraindication for oral anticoagulation at randomisation.
Show all 12Show fewer
- Intracerebral bleeding in medical history iv. Patient scheduled for ECG-monitoring lasting > 7 days (Holter-ECG, implanted loop recorder, etc.).
- Implanted pacemaker device or cardioverter/defibrillator or implanted cardiac monitor.
- Patient not willing to be treated with oral anticoagulants vii. Carotid artery stenosis ipsilateral to the current ischemic stroke needing operation or intervention.
- History of carotid endarterectomy or percutaneous stent intervention of cerebral or cervical artery within the last 30 days.
- Life expectancy <1 year for reasons other than stroke (e.g. metastatic cancer).
- Patients under legal supervision or guardianship xi. Psychological/mental or other inabilities to supply required information (e.g. fill out the questionnaire due to dementia, language difficulties, ... ) or participate in the required tests xii. Participation in other randomized interventional trials xiii. Suspected lack of compliance
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
RHÖN-KLINIKUM Campus Bad Neustadt Von-Guttenberg-Straße 11 Akutneurologie II - Stroke Unit - klinische Forschung
Bad Neustadt an der Saale, 97616
Evangelisches Klinikum Bethel, Clinic for Neurology
Bielefeld, 33611
Medizinische Fakultät Carl Gustav Carus Klinik und Poliklinik für Neurologie
Dresden
Universitätklinikum Erlangen Neurologische Klinik, Schwabachanlage 6
Erlangen, 91054
University of Essen, Clinic of Neurology
Essen, 45147
University of Göttingen, Clinic for Neurology
Göttingen, 37075
Krankenhaus Martha-Maria Halle-Dölau
Halle, 06120
Klinik für Neurologie Klinikum Ibbenbüren Große Str. 41
Ibbenbueren, 49477
University Hospital Leipzig, Clinic for Neurology
Leipzig, 04103
University of Mainz, Clinic for Neurology
Mainz, 55131
Johannes Wesling Klinikum Minden Universitätsklinik für Neurologie und Neurogeriatrie Hans-Nolte-Str. 1
Minden, 32429
Klinik für Neurologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Breslauer Str. 201
Nuremberg, 90471
Kliniken Südostbayern AG, Klinikum Traunstein
Traunstein, 83278
About this study
Official title: Pilot Study for SmartWatch-driven AF Detection in Stroke Patients
Unrecognized atrial fibrillation (AF) is a common cause of ischemic stroke. Implantable event monitors (ICM) are the gold standard for continuous heart rhythm monitoring but they have been implemented in very few patients after stroke due to high invasiveness and high costs.
In this trial, patients with implanted ICMs (Medtronic Reveal LINQ Insertable Cardiac Monitor) will be randomized to use one of two wearables (1:1 Apple Watch or PulseOn) for continuous monitoring. The aim is to compare the probability of detecting an episode of AF with a wearable versus the gold standard ICM.
Read more
Both groups will use the wearable for 12 weeks. If the wearables detect an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed. ECG data will be transferred regularly to the CoreLab (Universityhospital Leipzig) for analysis.
After 12 weeks, the patients will visit the site and answer questions regarding the usability, compliance and satisfaction with the wearables.
Read the detailed description
Patients with established continuous ICM monitoring from the prospective, randomized, multicenter study Find-AF 2 (NCT04371055) are recruited for this trial. Find-AF 2 is being carried out at Leipzig University Hospital since 2020 with the help of about 50 study centers throughout Germany.
The AppleWatch Series 10, a device from the current market leader, was chosen because extensive data from clinical trials is already available and data regarding the market leader has particular societal relevance. The AF detection algorithm is based on photoplethysmography (analysis of the pulse current curve) and semicontinuous monitoring. If a rhythm irregularity is detected during hourly measurements, the measurement interval is shortened. If this finding is confirmed in several consecutive measurements, the user is notified. In this pilot study, patients are trained to record a 30-second ECG with the AppleWatch in the event of notification. This is done by placing the other hand on the crown of the watch. The report will then be transmitted. The AppleWatch must be paired with another Apple device (e.g. iPhone) to use the ECG app and must be charged daily (battery life 18 hours). Our patients are provided with an iPhone for study use and are trained in using the AppleWatch.
The AppleWatch is not certified as medical device, but the ECG data collected by the AppleWatch will be used for research purposes only and not for therapeutical or diagnostical purposes.
The second wearable will be the PulseOn device. The battery lasts over two weeks. No additional device is needed for writing an ECG. AF screening is also performed photoplethysmographically. In the case of detection of an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed for registration. Regular data transfer is done at the patient's home via a gateway device to the PulseOn server. The Core lab will monitor the data transmission. Although PulseOn is a certified medical device, the ECG data collected by the PulseOn device will be used for research purposes only and not for therapeutical or diagnostical purposes. The ICM is the gold standard for recording relevant arrhythmias.
- Conditions
- Atrial Fibrillation (AF), Ischemic Stroke, ECG Monitoring, Secondary Prevention, Wearables
- Being tested
- Wearable
- Keywords
- ECG monitoring, ICM, Wearables, Stroke, ischemic stroke, atrial fibrillation, secondary prevention
- Medical subject headings
- Atrial Fibrillation, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WearableDevice
semi-continuous heart rhythm monitoring with Wearable
| Study group | Role | What they receive |
|---|---|---|
| AppleWatch | Experimental | semi-continuous heart rhythm monitoring with AppleWatch
for 12 weeks Receives: Device: Wearable |
| PulseOn | Experimental | semi-continuous heart rhythm monitoring with PulseOn device
for 12 weeks Receives: Device: Wearable |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity as a function of AF duration
the probability that an AF episode will be detected as it depends on the duration of the episode
Measured: from the date of device handover to the date of device return
Secondary outcomes (11)
Time worn
the proportion of time that the wearable collected and transferred data
Measured: from the date of device handover to the date of device return
Detection sensitivity as a function of AF duration
If the device is being worn during at least 120 seconds of an AF episode, what is the probability of its informing the patient of an arrhythmia?
Measured: from the date of device handover to the date of device return
ECG compliance
if the wearable informs of an episode, what is the probability that the patient will let the device save an ECG
Measured: from the date of device handover to the date of device return
Overall sensitivity
For patients who had at least one AF episode, what is the probability that the wearable claims there was at least one episode?
Measured: from the date of device handover to the date of device return
Time to first ECG-confirmed AF episode
Measured: from the date of device handover to the date of device return
Overall specificity
for patients who had no AF episodes, what is the probability that there is no ECG confirmation of any episodes?
Measured: from the date of device handover to the date of device return
False discovery rate (1-PPV (positive predictive value)
For every ECG-confirmed episode found by the wearable, the gold standard episode definition will be used for comparison
Measured: from the date of device handover to the date of device return
For the ICM: What proportion of detected signals are available as ECGs?
Measured: from the date of device handover to the date of device return
For the ICM: What is the false discovery rate of the available ECGs?
Measured: from the date of device handover to the date of device return
Do patients with an ICM claim to be willing to be randomized to an ICM vs a wearable?
Measured: after 12 weeks
Patient satisfaction with the wearable
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start15 May 2025
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, parallel, multicenter interventional trial
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Wachter, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832579
- Sponsor's protocol ID
- Find-AF2 Watch
- Acronym
- Find-AF2 Watch
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for SmartWatch-driven AF Detection in Stroke Patients
- ClinicalTrials.gov ID
- NCT06832579
- Acronym / sponsor ID
- Find-AF2 Watch / Find-AF2 Watch
- Conditions
- Atrial Fibrillation (AF), Ischemic Stroke, ECG Monitoring, Secondary Prevention, Wearables
- Keywords
- ECG monitoring, ICM, Wearables, Stroke, ischemic stroke, atrial fibrillation, secondary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 15 May 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 18 Feb 2025 (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.
Unrecognized atrial fibrillation (AF) is a common cause of ischemic stroke. Implantable event monitors (ICM) are the gold standard for continuous heart rhythm monitoring but they have been implemented in very few patients after stroke due to high invasiveness and high costs.
In this trial, patients with implanted ICMs (Medtronic Reveal LINQ Insertable Cardiac Monitor) will be randomized to use one of two wearables (1:1 Apple Watch or PulseOn) for continuous monitoring. The aim is to compare the probability of detecting an episode of AF with a wearable versus the gold standard ICM.
Both groups will use the wearable for 12 weeks. If the wearables detect an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed. ECG data will be transferred regularly to the CoreLab (Universityhospital Leipzig) for analysis.
After 12 weeks, the patients will visit the site and answer questions regarding the usability, compliance and satisfaction with the wearables.
Detailed description
Patients with established continuous ICM monitoring from the prospective, randomized, multicenter study Find-AF 2 (NCT04371055) are recruited for this trial. Find-AF 2 is being carried out at Leipzig University Hospital since 2020 with the help of about 50 study centers throughout Germany.
The AppleWatch Series 10, a device from the current market leader, was chosen because extensive data from clinical trials is already available and data regarding the market leader has particular societal relevance. The AF detection algorithm is based on photoplethysmography (analysis of the pulse current curve) and semicontinuous monitoring. If a rhythm irregularity is detected during hourly measurements, the measurement interval is shortened. If this finding is confirmed in several consecutive measurements, the user is notified. In this pilot study, patients are trained to record a 30-second ECG with the AppleWatch in the event of notification. This is done by placing the other hand on the crown of the watch. The report will then be transmitted. The AppleWatch must be paired with another Apple device (e.g. iPhone) to use the ECG app and must be charged daily (battery life 18 hours). Our patients are provided with an iPhone for study use and are trained in using the AppleWatch.
The AppleWatch is not certified as medical device, but the ECG data collected by the AppleWatch will be used for research purposes only and not for therapeutical or diagnostical purposes.
The second wearable will be the PulseOn device. The battery lasts over two weeks. No additional device is needed for writing an ECG. AF screening is also performed photoplethysmographically. In the case of detection of an arrhythmic pulse curve, this is communicated by vibration. By laying the other hand on the device, a 1-channel ECG is performed for registration. Regular data transfer is done at the patient's home via a gateway device to the PulseOn server. The Core lab will monitor the data transmission. Although PulseOn is a certified medical device, the ECG data collected by the PulseOn device will be used for research purposes only and not for therapeutical or diagnostical purposes. The ICM is the gold standard for recording relevant arrhythmias.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised, parallel, multicenter interventional trial
| Arm | Type | Receives |
|---|---|---|
| AppleWatch | Experimental | Device: Wearablesemi-continuous heart rhythm monitoring with AppleWatch for 12 weeks |
| PulseOn | Experimental | Device: Wearablesemi-continuous heart rhythm monitoring with PulseOn device for 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Study participation in Find-AF 2
- Randomization in the intervention arm of the Find-AF 2 study and presence of an implanted event recorder (Medtronic Reveal LINQTM Insertable Cardiac Monitor)
- Signed informed consent
- All inclusion criteria of the Find-AF 2 study are met (according to protocol version Final 4.0, dated 08.05.2024):
- Age ≥ 60 years. iii. Patient without or with only slight disability (modified Rankin Scale score ≤ 2) before onset of stroke-related symtoms.
Key exclusion criteria (12 listed)
- Expiration of the battery of the event recorder in <3 months
- No in ICM data transmission possible (e. g. missing compliance)
- Poor ECG data quality according to core lab evaluation (e.g. permanent oversensing), which prevents meaningful evaluation of the event recorder data
- Exclusion criteria of the Find-AF 2 study (according to protocol version Final 4.0, dated 08.05.2024):
- Current indication or contraindication for oral anticoagulation at randomisation.
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 |
|---|---|---|
| Wearablesemi-continuous heart rhythm monitoring with Wearable | Device | AppleWatch, PulseOn |
Primary outcome
sensitivity as a function of AF duration
Time frame: from the date of device handover to the date of device return
the probability that an AF episode will be detected as it depends on the duration of the episode
11 secondary outcomes
Time worn
Time frame: from the date of device handover to the date of device return
Detection sensitivity as a function of AF duration
Time frame: from the date of device handover to the date of device return
ECG compliance
Time frame: from the date of device handover to the date of device return
Overall sensitivity
Time frame: from the date of device handover to the date of device return
Time to first ECG-confirmed AF episode
Time frame: from the date of device handover to the date of device return
Overall specificity
Time frame: from the date of device handover to the date of device return
False discovery rate (1-PPV (positive predictive value)
Time frame: from the date of device handover to the date of device return
For the ICM: What proportion of detected signals are available as ECGs?
Time frame: from the date of device handover to the date of device return
For the ICM: What is the false discovery rate of the available ECGs?
Time frame: from the date of device handover to the date of device return
Do patients with an ICM claim to be willing to be randomized to an ICM vs a wearable?
Time frame: after 12 weeks
Patient satisfaction with the wearable
Time frame: after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable in people with Atrial Fibrillation (AF) and Ischemic Stroke, run by University of Leipzig at 13 sites in Germany.
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 8 inclusion and 12 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: finished, as of the sponsor's last update on 26 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 13 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity as a function of AF duration (time frame: from the date of device handover to the date of device return). 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 26 Aug 2026.