Atrial Fibrillation (AF)CATCH-AFNCT07899788
CATCH AF - Atrial Fibrillation Detection in Cryptogenic Stroke
A study testing CardioWatch 287-2 Group in people with Atrial Fibrillation (AF), run by Medical University of Graz at 1 site in Austria.
Trial summary
Early detection of atrial fibrillation detected after stroke (AFDAS) is crucial for secondary stroke prevention, as initiating direct oral anticoagulants (DOACs) can reduce atrial fibrillation (AF)-related stroke risk by up to 60%. 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?
- CardioWatch 287-2 Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteAustria
- Study dates
- 1 Oct 2026to 31 Aug 2030
- 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
- All cryptogenic stroke patients (imaging-based definition) admitted at one of the five Neurology Departments in the Province of Styria.
- Age ≥18 years
Who cannot join
- Patients with transitory ischemic attack
- Patients with primary intracranial bleeding
- No written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Medical University of Graz, Department of Neurology
Graz, Styria, 8036
About this study
Official title: Continuous Arrhythmia Monitoring to Identify Atrial Fibrillation in Cryptogenic Ischemic Stroke - The CATCH AF Study
Early detection of atrial fibrillation detected after stroke (AFDAS) is crucial for secondary stroke prevention, as initiating direct oral anticoagulants (DOACs) can reduce atrial fibrillation (AF)-related stroke risk by up to 60%. In cryptogenic stroke (CS), AFDAS likely represents the most frequent underlying etiology, yet paroxysmal and short-duration AF episodes often elude standard monitoring. The Graz AF Risk Score, implemented across all Neurology Departments in Styria, Austria, stratifies patients into tailored monitoring pathways but remains limited by delays in implantable loop recorder (ILR) implantation, patient refusal, and restricted access to early ambulatory ECG monitoring.
The study aims to close diagnostic gaps in the current AF detection pathway by implementing a non-invasive, wrist-worn photoplethysmography (PPG) device (i.e., CardioWatch 287-2 [CW2]) for early cardiac rhythm monitoring in CS patients.
Read more
Methods:
CATCH-AF is an investigator-initiated, prospective, longitudinal, multi-center, pre-post interventional study including all CS patients admitted to one of five Styrian Neurology Departments. In the pre-intervention phase, AF detection will follow the established Graz AF Risk Score-based algorithm. In the intervention phase, CardioWatch 287-2 screening will replace Holter-ECG screening in moderate-risk patients and will be used for high-risk patients with delayed or declined ILR implantation. Suspected AF episodes will be confirmed by ECG- based assessment at the discretion of the treating cardiologist. The primary endpoint isAFDAS detection at 3 months; secondary endpoints include AFDAS at 12 months, time to AF detection and DOAC initiation, cerebrovascular event recurrence, cardiovascular death, and all-cause mortality at 3 and 12 months. Data will be collected via REDCap and analyzed using descriptive, univariable, and multivariable regression methods, adjusted for confounders with inverse probability of treatment weighting.
The investigators hypothesize that CardioWatch 287-2 implementation will increase early AFDAS detection and reduce diagnostic and therapeutic delays, potentially lowering recurrent cerebrovascular events and mortality over 12 months.
CATCH-AF represents the first European, population-wide evaluation of a wrist-worn PPG device integrated into an established AF detection pathway for cryptogenic stroke, aiming to improve early diagnosis, treatment initiation and secondary prevention outcomes.
Read the detailed description
Background:
The early identification of atrial fibrillation detected after stroke (AFDAS) is essential to optimize secondary stroke prevention, as the initiation of direct oral anticoagulants (DOACs) reduces atrial fibrillation (AF)-related stroke risk by up to 60%. However, AFDAS often occurs paroxysmal and in short episodes, which complicates its detection. In acute ischemic stroke of undetermined source after the initial workup (=cryptogenic stroke, CS), AFDAS may represent the most frequent etiology. Randomized clinical trials (NAVIGATE ESUS, RESPECT ESUS, ATTICUS) failed to demonstrate superiority of treating unselected CS patients with direct oral anticoagulants (DOACs) compared to standard antiplatelet treatment. Moreover, the recently published ARCADIA trial was not able to identify a reduction in recurrent ischemic stroke using Apixaban in cryptogenic stroke patients with echocardiographic and/or laboratory signs of atrial cardiopathy.
These results support the necessity for detecting AF in CS patients, but costs and availability in daily clinical routine represent barriers in the use of prolonged cardiac rhythm monitoring.
Therefore, a clinical risk score based on electrocardiographic, echocardiographic, neuroimaging, and blood biomarkers (Graz AF Risk Score) was developed and implemented across all hospitals in the Province of Styria, Austria, which collectively provide care for more than 2,000 stroke patients annually. The score, routinely applied within the first days after admission, determines the subsequent AF detection strategy. Patients with low scores (0-1 points) do not undergo further cardiac rhythm monitoring (negative predictive value: >99%). Those with scores of 2 or 3 receive further ambulatory ECG monitoring of at least 24 hours, while patients with scores ≥4 are offered an implantable loop recorder.
To the best of our knowledge, this is the largest continuously evaluated AF detection pathway of CS patients in Europe. Despite its success in improving AF identification rates, recent findings highlight important limitations.
Limitations of present diagnostic pathway
The present pathway is constrained by significant limitations:
- Delay to monitoring start: Although implantation of implantable loop recorders is typically recommended during hospital stay, delays of more than 7 days are often observed. A recent pooled-data analysis conducted by our group in collaboration with the international multicenter BIOSIGNAL study (Hatab I, Kneihsl M, STROKE 2025) highlighted the importance of early AFDAS detection. Closing the diagnostic gap using more readily available and applicable tools, such as the CardioWatch 287-2 (CW2), could significantly improve early AF detection rates.
- Refusal of implantable devices: Based on our data, one in every five patients declines loop recorder implantation, opting instead for non-invasive monitoring techniques. However, in daily clinical practice, access to alternatives that monitor for at least 24 hours is limited. Therefore, non-invasive and more easily available monitoring tools capable of cardiac rhythm monitoring are needed to improve AFDAS detection.
- Moderate risk patients:
According to the Graz AF Risk score, individuals with scores of 2 to 3 points undergo prolonged cardiac rhythm monitoring through ambulatory ECG monitoring of at least 24 hours. However, early availability is limited, which might reduce its effectiveness for early AFDAS detection.
Aims and hypothesis Primary aims and hypotheses The primary objective of this project (CATCH AF) is to improve AFDAS detection in CS patients by closing the diagnostic gaps using a non-invasive easily applicable cardiac rhythm monitoring tool, i.e. the CardioWatch 287-2 (CW2).
Secondary aims and hypotheses As secondary objectives, we aim
- to analyze if the use of a non-invasive AFDAS screening tool can reduce the time from admission to AFDAS detection.
- to analyze if the implementation of an additional non-invasive AFDAS screening tool would lead to a reduction in cerebrovascular events and lower mortality over a 12 months follow-up period.
Clinical innovation of the project To the best of our knowledge, this proposed project would be the first to utilize a wrist-worn photoplethysmography (PPG) device for cardiac rhythm monitoring (i.e., CardioWatch 287-2 (CW2), as an adjunct to close diagnostic gaps in AFDAS detection.
Furthermore, the project will employ an internationally recognized diagnostic pathway that is under continuous evaluation. This unique approach allows for a pre- and post-analysis, with the CardioWatch 287-2 (CW2) serving as the intervention. It will provide valuable insights into the benefits of using additional devices to improve AFDAS detection rates and reduce diagnostic delays.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- CardioWatch 287-2 Group, Control Group
- Keywords
- Stroke, atrial fibrillation, ESUS
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioWatch 287-2 GroupDevice
- Low Risk (Graz AF Risk Score: 0-1 points, negative predictive value: >99%): No additional monitoring will be done
- Moderate Risk (Graz AF Risk Score: 2-3 points): CardioWatch 287-2 (CW2) will be used in all patients whose stroke etiology remains cryptogenic after the initial work-up instead of Holter-ECG.
- High Risk (Graz AF Risk Score: >= 4 points): An implantable loop recorder implantation will be offered. If there is a delay of more than 7 days before implantation, or if the patient refuses the procedure, a CardioWatch 287-2 (CW2) will be used instead of the Holter-ECG.
Control GroupDevice
- Low Risk (Graz AF Risk Score: 0-1 points, negative predictive value: >99%): No additional monitoring will be done
- Moderate Risk (Graz AF Risk Score: 2-3 points): An ambulatory Holter-ECG of at least 24 hours will be used to monitor for covert AF
- High Risk (Graz AF Risk Score: >= 4 points): An implantable loop recorder implantation will be offered. If there is a delay of more than 7 days before implantation, or if the patient refuses the procedure, a Holter-ECG of at least 24 hours will be used instead.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | During the pre-interventional observation period, all participating Neurology Departments will continue their routine clinical care without implementing any additional study-specific AF-detection measures.
This includes in-depth investigation of stroke etiology using a guideline-based thorough and standardized diagnostic workup including brain imaging (mostly MRI), ultrasound and / or MRI-based investigation of brain-supplying vessels, electrocardiogram (ECG), ECG-monitoring for 48 hours and echocardiography. In patients whose stroke etiology remains cryptogenic after the guideline-based work-up, prolonged cardiac rhythm monitoring is based on a uniform algorithm including a clinical risk score (i.e., Graz AF Risk Score) as proposed by Kneihsl et al. in 2022 and which has already been established in all Neurology Departments of the Province of Styria, Austria. Receives: Device: Control Group |
| CardioWatch 287-2 Group | Other | To close diagnostic gaps of the present diagnostic pathway (i.e., Delay to ECG-Holter monitoring start, Refusal of implantable devices) the CardioWatch 287-2 (CW2) will be implemented as wearable PPG based diagnostic tool to identify AF in CS patients in all five Styrian Neurology Departments. Receives: Device: CardioWatch 287-2 Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of atrial fibrillation detected after stroke (AFDAS) within 3 months post-stroke
Proportion of participants with AFDAS detected within 3 months after the index stroke. Define AFDAS according to the study protocol.
Unit of Measure: Participants / %
Measured: 3 months post-stroke
Secondary outcomes (13)
Occurrence of AFDAS within 12 months post-stroke
Proportion of participants with AFDAS detected within 12 months after the index stroke. Unit of Measure: Participants / %
Measured: 12 months after index stroke
Time to first AFDAS detection
Time from the index stroke to first documented detection of AFDAS. Unit of measure: Days
Measured: Up to 12 months after index stroke
Time to initiation of direct oral anticoagulant (DOAC) therapy
Time from the index stroke to initiation of DOAC therapy. Specify the analysis population according to the protocol.
Unit of measure: Days
Measured: Up to 12 months after index stroke
Occurrence of recurrent ischemic stroke within 3 months post-stroke
Proportion of participants experiencing recurrent ischemic stroke within 3 months after the index stroke.
Unit of measure: Participants / %
Measured: 3 months after the index stroke
Occurrence of myocardial infarction within 3 months post-stroke
Proportion of participants experiencing myocardial infarction within 3 months after the index stroke.
Unit of measure: Participants / %
Measured: 3 months after the index stroke
Occurrence of acute peripheral arterial occlusion within 3 months post-stroke
Proportion of participants experiencing acute peripheral arterial occlusion within 3 months after the index stroke.
Unit of measure: Participants / %
Measured: 3 months after the index stroke
Occurrence of recurrent ischemic stroke within 12 months post-stroke
Proportion of participants experiencing recurrent ischemic stroke within 12 months after the index stroke.
Unit of measure: Participants / %
Measured: 12 months after the index stroke
Occurrence of myocardial infarction within 12 months post-stroke
Proportion of participants experiencing myocardial infarction within 12 months after the index stroke.
Unit of measure: Participants / %
Measured: 12 months after the index stroke
Occurrence of acute peripheral arterial occlusion within 12 months post-stroke
Proportion of participants experiencing acute peripheral arterial occlusion within 12 months after the index stroke.
Unit of measure:
Measured: 12 months after the index stroke
Cardiovascular mortality within 3 months post-stroke
Proportion of participants who die from a cardiovascular cause within 3 months after the index stroke.
Unit measure: Participants / %
Measured: 3 months after the index stroke
Cardiovascular mortality within 12 months post-stroke
Proportion of participants who die from a cardiovascular cause within 12 months after the index stroke.
Unit of measure: Participants / %
Measured: 12 months after the index stroke
All-cause mortality within 3 months post-stroke
Proportion of participants who die from any cause within 3 months after the index stroke.
Unit of measure: Participants / %
Measured: 3 months after the index stroke
All-cause mortality within 12 months post-stroke
Proportion of participants who die from any cause within 12 months after the index stroke.
Unit of measure: Participants / %
Measured: 12 months after the index stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The CATCH AF study is an investigator-initiated prospective, longitudinal, interventional, 140 multi-center, pre-post study. We aim at including all CS patients who are admitted at one of 141 the five Neurology Departments of the Province of Styria starting in 2026.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899788
- Sponsor's protocol ID
- 1176/2026
- Other IDs
- ERP-2025-14457
- Acronym
- CATCH-AF
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berger N, Brunner A, Wunsch G, Nistl O, Pinter D, Fandler-Hofler S, Haidegger M, Pichler A, Hatab I, Mokry M, Wolfsberger S, Enzinger C, Gattringer T, Kneihsl M. Long-term outcome after decompressive hemicraniectomy for malignant middle cerebral artery infarction. J Neurol. 2023 Jul;270(7):3475-3482. doi: 10.1007/s00415-023-11679-1. Epub 2023 Apr 1.
PubMed 37004558Kneihsl M, Hinteregger N, Nistl O, Deutschmann H, Horner S, Poltrum B, Fandler-Hofler S, Hatab I, Haidegger M, Pinter D, Pichler A, Willeit K, Knoflach M, Enzinger C, Gattringer T. Post-reperfusion hyperperfusion after endovascular stroke treatment: a prospective comparative study of TCD versus MRI. J Neurointerv Surg. 2023 Oct;15(10):983-988. doi: 10.1136/jnis-2022-019213. Epub 2022 Sep 22.
PubMed 36137745Kneihsl M, Bisping E, Scherr D, Mangge H, Fandler-Hofler S, Colonna I, Haidegger M, Eppinger S, Hofer E, Fazekas F, Enzinger C, Gattringer T. Predicting atrial fibrillation after cryptogenic stroke via a clinical risk score-a prospective observational study. Eur J Neurol. 2022 Jan;29(1):149-157. doi: 10.1111/ene.15102. Epub 2021 Sep 23.
PubMed 34519135Kneihsl M, Hofer E, Enzinger C, Niederkorn K, Horner S, Pinter D, Fandler-Hofler S, Eppinger S, Haidegger M, Schmidt R, Gattringer T. Intracranial Pulsatility in Relation to Severity and Progression of Cerebral White Matter Hyperintensities. Stroke. 2020 Nov;51(11):3302-3309. doi: 10.1161/STROKEAHA.120.030478. Epub 2020 Sep 4.
PubMed 32883195Kneihsl M, Gattringer T, Bisping E, Scherr D, Raggam R, Mangge H, Enzinger C, Fandler-Hofler S, Eppinger S, Hermetter C, Bucnik B, Poltrum B, Niederkorn K, Fazekas F. Blood Biomarkers of Heart Failure and Hypercoagulation to Identify Atrial Fibrillation-Related Stroke. Stroke. 2019 Aug;50(8):2223-2226. doi: 10.1161/STROKEAHA.119.025339. Epub 2019 Jun 20.
PubMed 31216968Kneihsl M, Niederkorn K, Deutschmann H, Enzinger C, Poltrum B, Horner S, Thaler D, Kraner J, Fandler S, Colonna I, Fazekas F, Gattringer T. Abnormal Blood Flow on Transcranial Duplex Sonography Predicts Poor Outcome After Stroke Thrombectomy. Stroke. 2018 Nov;49(11):2780-2782. doi: 10.1161/STROKEAHA.118.023213.
PubMed 30355211Kneihsl M, Enzinger C, Niederkorn K, Wunsch G, Muller L, Culea V, Lueger A, Fazekas F, Gattringer T. Stroke Referrals from Nursing Homes: High Rate of Mimics and Late Presentation. Cerebrovasc Dis. 2018;45(3-4):109-114. doi: 10.1159/000487813. Epub 2018 Mar 14.
PubMed 29539602Kneihsl M, Niederkorn K, Deutschmann H, Enzinger C, Poltrum B, Fischer R, Thaler D, Hermetter C, Wunsch G, Fazekas F, Gattringer T. Increased middle cerebral artery mean blood flow velocity index after stroke thrombectomy indicates increased risk for intracranial hemorrhage. J Neurointerv Surg. 2018 Sep;10(9):882-887. doi: 10.1136/neurintsurg-2017-013617. Epub 2017 Dec 28.
PubMed 29288194
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Arrhythmia Monitoring to Identify Atrial Fibrillation in Cryptogenic Ischemic Stroke - The CATCH AF Study
- ClinicalTrials.gov ID
- NCT07899788
- Acronym / sponsor ID
- CATCH-AF / 1176/2026
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Stroke, atrial fibrillation, ESUS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 28 Oct 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.
Early detection of atrial fibrillation detected after stroke (AFDAS) is crucial for secondary stroke prevention, as initiating direct oral anticoagulants (DOACs) can reduce atrial fibrillation (AF)-related stroke risk by up to 60%. In cryptogenic stroke (CS), AFDAS likely represents the most frequent underlying etiology, yet paroxysmal and short-duration AF episodes often elude standard monitoring. The Graz AF Risk Score, implemented across all Neurology Departments in Styria, Austria, stratifies patients into tailored monitoring pathways but remains limited by delays in implantable loop recorder (ILR) implantation, patient refusal, and restricted access to early ambulatory ECG monitoring.
The study aims to close diagnostic gaps in the current AF detection pathway by implementing a non-invasive, wrist-worn photoplethysmography (PPG) device (i.e., CardioWatch 287-2 [CW2]) for early cardiac rhythm monitoring in CS patients.
Methods:
CATCH-AF is an investigator-initiated, prospective, longitudinal, multi-center, pre-post interventional study including all CS patients admitted to one of five Styrian Neurology Departments. In the pre-intervention phase, AF detection will follow the established Graz AF Risk Score-based algorithm. In the intervention phase, CardioWatch 287-2 screening will replace Holter-ECG screening in moderate-risk patients and will be used for high-risk patients with delayed or declined ILR implantation. Suspected AF episodes will be confirmed by ECG- based assessment at the discretion of the treating cardiologist. The primary endpoint isAFDAS detection at 3 months; secondary endpoints include AFDAS at 12 months, time to AF detection and DOAC initiation, cerebrovascular event recurrence, cardiovascular death, and all-cause mortality at 3 and 12 months. Data will be collected via REDCap and analyzed using descriptive, univariable, and multivariable regression methods, adjusted for confounders with inverse probability of treatment weighting.
The investigators hypothesize that CardioWatch 287-2 implementation will increase early AFDAS detection and reduce diagnostic and therapeutic delays, potentially lowering recurrent cerebrovascular events and mortality over 12 months.
CATCH-AF represents the first European, population-wide evaluation of a wrist-worn PPG device integrated into an established AF detection pathway for cryptogenic stroke, aiming to improve early diagnosis, treatment initiation and secondary prevention outcomes.
Detailed description
Background:
The early identification of atrial fibrillation detected after stroke (AFDAS) is essential to optimize secondary stroke prevention, as the initiation of direct oral anticoagulants (DOACs) reduces atrial fibrillation (AF)-related stroke risk by up to 60%. However, AFDAS often occurs paroxysmal and in short episodes, which complicates its detection. In acute ischemic stroke of undetermined source after the initial workup (=cryptogenic stroke, CS), AFDAS may represent the most frequent etiology. Randomized clinical trials (NAVIGATE ESUS, RESPECT ESUS, ATTICUS) failed to demonstrate superiority of treating unselected CS patients with direct oral anticoagulants (DOACs) compared to standard antiplatelet treatment. Moreover, the recently published ARCADIA trial was not able to identify a reduction in recurrent ischemic stroke using Apixaban in cryptogenic stroke patients with echocardiographic and/or laboratory signs of atrial cardiopathy.
These results support the necessity for detecting AF in CS patients, but costs and availability in daily clinical routine represent barriers in the use of prolonged cardiac rhythm monitoring.
Therefore, a clinical risk score based on electrocardiographic, echocardiographic, neuroimaging, and blood biomarkers (Graz AF Risk Score) was developed and implemented across all hospitals in the Province of Styria, Austria, which collectively provide care for more than 2,000 stroke patients annually. The score, routinely applied within the first days after admission, determines the subsequent AF detection strategy. Patients with low scores (0-1 points) do not undergo further cardiac rhythm monitoring (negative predictive value: >99%). Those with scores of 2 or 3 receive further ambulatory ECG monitoring of at least 24 hours, while patients with scores ≥4 are offered an implantable loop recorder.
To the best of our knowledge, this is the largest continuously evaluated AF detection pathway of CS patients in Europe. Despite its success in improving AF identification rates, recent findings highlight important limitations.
Limitations of present diagnostic pathway
The present pathway is constrained by significant limitations:
- Delay to monitoring start: Although implantation of implantable loop recorders is typically recommended during hospital stay, delays of more than 7 days are often observed. A recent pooled-data analysis conducted by our group in collaboration with the international multicenter BIOSIGNAL study (Hatab I, Kneihsl M, STROKE 2025) highlighted the importance of early AFDAS detection. Closing the diagnostic gap using more readily available and applicable tools, such as the CardioWatch 287-2 (CW2), could significantly improve early AF detection rates.
- Refusal of implantable devices: Based on our data, one in every five patients declines loop recorder implantation, opting instead for non-invasive monitoring techniques. However, in daily clinical practice, access to alternatives that monitor for at least 24 hours is limited. Therefore, non-invasive and more easily available monitoring tools capable of cardiac rhythm monitoring are needed to improve AFDAS detection.
- Moderate risk patients:
According to the Graz AF Risk score, individuals with scores of 2 to 3 points undergo prolonged cardiac rhythm monitoring through ambulatory ECG monitoring of at least 24 hours. However, early availability is limited, which might reduce its effectiveness for early AFDAS detection.
Aims and hypothesis Primary aims and hypotheses The primary objective of this project (CATCH AF) is to improve AFDAS detection in CS patients by closing the diagnostic gaps using a non-invasive easily applicable cardiac rhythm monitoring tool, i.e. the CardioWatch 287-2 (CW2).
Secondary aims and hypotheses As secondary objectives, we aim
- to analyze if the use of a non-invasive AFDAS screening tool can reduce the time from admission to AFDAS detection.
- to analyze if the implementation of an additional non-invasive AFDAS screening tool would lead to a reduction in cerebrovascular events and lower mortality over a 12 months follow-up period.
Clinical innovation of the project To the best of our knowledge, this proposed project would be the first to utilize a wrist-worn photoplethysmography (PPG) device for cardiac rhythm monitoring (i.e., CardioWatch 287-2 (CW2), as an adjunct to close diagnostic gaps in AFDAS detection.
Furthermore, the project will employ an internationally recognized diagnostic pathway that is under continuous evaluation. This unique approach allows for a pre- and post-analysis, with the CardioWatch 287-2 (CW2) serving as the intervention. It will provide valuable insights into the benefits of using additional devices to improve AFDAS detection rates and reduce diagnostic delays.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The CATCH AF study is an investigator-initiated prospective, longitudinal, interventional, 140 multi-center, pre-post study. We aim at including all CS patients who are admitted at one of 141 the five Neurology Departments of the Province of Styria starting in 2026.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Device: Control GroupDuring the pre-interventional observation period, all participating Neurology Departments will continue their routine clinical care without implementing any additional study-specific AF-detection measures. This includes in-depth investigation of stroke etiology using a guideline-based thorough and standardized diagnostic workup including brain imaging (mostly MRI), ultrasound and / or MRI-based investigation of brain-supplying vessels, electrocardiogram (ECG), ECG-monitoring for 48 hours and echocardiography. In patients whose stroke etiology remains cryptogenic after the guideline-based work-up, prolonged cardiac rhythm monitoring is based on a uniform algorithm including a clinical risk score (i.e., Graz AF Risk Score) as proposed by Kneihsl et al. in 2022 and which has already been established in all Neurology Departments of the Province of Styria, Austria. |
| CardioWatch 287-2 Group | Other | Device: CardioWatch 287-2 GroupTo close diagnostic gaps of the present diagnostic pathway (i.e., Delay to ECG-Holter monitoring start, Refusal of implantable devices) the CardioWatch 287-2 (CW2) will be implemented as wearable PPG based diagnostic tool to identify AF in CS patients in all five Styrian Neurology Departments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All cryptogenic stroke patients (imaging-based definition) admitted at one of the five Neurology Departments in the Province of Styria.
- Age ≥18 years
Key exclusion criteria (3 listed)
- Patients with transitory ischemic attack
- Patients with primary intracranial bleeding
- No written informed consent
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 |
|---|---|---|
| CardioWatch 287-2 Group* Low Risk (Graz AF Risk Score: 0-1 points, negative predictive value: >99%): No additional monitoring will be done * Moderate Risk (Graz AF Risk Score: 2-3 points): CardioWatch 287-2 (CW2) will be used in all patients whose stroke etiology remains cryptogenic after the initial work-up instead of Holter-ECG. * High Risk (Graz AF Risk Score: >= 4 points): An implantable loop recorder implantation will be offered. If there is a delay of more than 7 days before implantation, or if the patient refuses the procedure, a CardioWatch 287-2 (CW2) will be used instead of the Holter-ECG. | Device | CardioWatch 287-2 Group |
| Control Group* Low Risk (Graz AF Risk Score: 0-1 points, negative predictive value: >99%): No additional monitoring will be done * Moderate Risk (Graz AF Risk Score: 2-3 points): An ambulatory Holter-ECG of at least 24 hours will be used to monitor for covert AF * High Risk (Graz AF Risk Score: >= 4 points): An implantable loop recorder implantation will be offered. If there is a delay of more than 7 days before implantation, or if the patient refuses the procedure, a Holter-ECG of at least 24 hours will be used instead. | Device | Control group |
Primary outcome
Occurrence of atrial fibrillation detected after stroke (AFDAS) within 3 months post-stroke
Time frame: 3 months post-stroke
Proportion of participants with AFDAS detected within 3 months after the index stroke. Define AFDAS according to the study protocol. Unit of Measure: Participants / %
13 secondary outcomes
Occurrence of AFDAS within 12 months post-stroke
Time frame: 12 months after index stroke
Time to first AFDAS detection
Time frame: Up to 12 months after index stroke
Time to initiation of direct oral anticoagulant (DOAC) therapy
Time frame: Up to 12 months after index stroke
Occurrence of recurrent ischemic stroke within 3 months post-stroke
Time frame: 3 months after the index stroke
Occurrence of myocardial infarction within 3 months post-stroke
Time frame: 3 months after the index stroke
Occurrence of acute peripheral arterial occlusion within 3 months post-stroke
Time frame: 3 months after the index stroke
Occurrence of recurrent ischemic stroke within 12 months post-stroke
Time frame: 12 months after the index stroke
Occurrence of myocardial infarction within 12 months post-stroke
Time frame: 12 months after the index stroke
Occurrence of acute peripheral arterial occlusion within 12 months post-stroke
Time frame: 12 months after the index stroke
Cardiovascular mortality within 3 months post-stroke
Time frame: 3 months after the index stroke
Cardiovascular mortality within 12 months post-stroke
Time frame: 12 months after the index stroke
All-cause mortality within 3 months post-stroke
Time frame: 3 months after the index stroke
All-cause mortality within 12 months post-stroke
Time frame: 12 months after the index stroke
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 29 Oct 2026.
- Background: PubMed 37004558Berger N, Brunner A, Wunsch G, Nistl O, Pinter D, Fandler-Hofler S, Haidegger M, Pichler A, Hatab I, Mokry M, Wolfsberger S, Enzinger C, Gattringer T, Kneihsl M. Long-term outcome after decompressive hemicraniectomy for malignant middle cerebral artery infarction. J Neurol. 2023 Jul;270(7):3475-3482. doi: 10.1007/s00415-023-11679-1. Epub 2023 Apr 1.
- Background: PubMed 36137745Kneihsl M, Hinteregger N, Nistl O, Deutschmann H, Horner S, Poltrum B, Fandler-Hofler S, Hatab I, Haidegger M, Pinter D, Pichler A, Willeit K, Knoflach M, Enzinger C, Gattringer T. Post-reperfusion hyperperfusion after endovascular stroke treatment: a prospective comparative study of TCD versus MRI. J Neurointerv Surg. 2023 Oct;15(10):983-988. doi: 10.1136/jnis-2022-019213. Epub 2022 Sep 22.
- Background: PubMed 34519135Kneihsl M, Bisping E, Scherr D, Mangge H, Fandler-Hofler S, Colonna I, Haidegger M, Eppinger S, Hofer E, Fazekas F, Enzinger C, Gattringer T. Predicting atrial fibrillation after cryptogenic stroke via a clinical risk score-a prospective observational study. Eur J Neurol. 2022 Jan;29(1):149-157. doi: 10.1111/ene.15102. Epub 2021 Sep 23.
- Background: PubMed 32883195Kneihsl M, Hofer E, Enzinger C, Niederkorn K, Horner S, Pinter D, Fandler-Hofler S, Eppinger S, Haidegger M, Schmidt R, Gattringer T. Intracranial Pulsatility in Relation to Severity and Progression of Cerebral White Matter Hyperintensities. Stroke. 2020 Nov;51(11):3302-3309. doi: 10.1161/STROKEAHA.120.030478. Epub 2020 Sep 4.
- Background: PubMed 31216968Kneihsl M, Gattringer T, Bisping E, Scherr D, Raggam R, Mangge H, Enzinger C, Fandler-Hofler S, Eppinger S, Hermetter C, Bucnik B, Poltrum B, Niederkorn K, Fazekas F. Blood Biomarkers of Heart Failure and Hypercoagulation to Identify Atrial Fibrillation-Related Stroke. Stroke. 2019 Aug;50(8):2223-2226. doi: 10.1161/STROKEAHA.119.025339. Epub 2019 Jun 20.
- Background: PubMed 30355211Kneihsl M, Niederkorn K, Deutschmann H, Enzinger C, Poltrum B, Horner S, Thaler D, Kraner J, Fandler S, Colonna I, Fazekas F, Gattringer T. Abnormal Blood Flow on Transcranial Duplex Sonography Predicts Poor Outcome After Stroke Thrombectomy. Stroke. 2018 Nov;49(11):2780-2782. doi: 10.1161/STROKEAHA.118.023213.
- Background: PubMed 29539602Kneihsl M, Enzinger C, Niederkorn K, Wunsch G, Muller L, Culea V, Lueger A, Fazekas F, Gattringer T. Stroke Referrals from Nursing Homes: High Rate of Mimics and Late Presentation. Cerebrovasc Dis. 2018;45(3-4):109-114. doi: 10.1159/000487813. Epub 2018 Mar 14.
- Background: PubMed 29288194Kneihsl M, Niederkorn K, Deutschmann H, Enzinger C, Poltrum B, Fischer R, Thaler D, Hermetter C, Wunsch G, Fazekas F, Gattringer T. Increased middle cerebral artery mean blood flow velocity index after stroke thrombectomy indicates increased risk for intracranial hemorrhage. J Neurointerv Surg. 2018 Sep;10(9):882-887. doi: 10.1136/neurintsurg-2017-013617. Epub 2017 Dec 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioWatch 287-2 Group in people with Atrial Fibrillation (AF), run by Medical University of Graz at 1 site in Austria.
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 2 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 Markus Kneihsl, Ass.-Prof. DDr. (+43 (0)316 385 ext. 82984, markus.kneihsl@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of atrial fibrillation detected after stroke (AFDAS) within 3 months post-stroke (time frame: 3 months post-stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899788, which also lists 8 linked publications.
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 29 Oct 2026.