Ischemic Stroke, CryptogenicWATCH AFibNCT06005233
Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke
A study testing Smartwatch in people with Ischemic Stroke, Cryptogenic and Transient Ischemic Attack, run by Technical University of Munich at 1 site in Germany.
Trial summary
Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Cryptogenic, Transient Ischemic Attack, Atrial Fibrillation
- What is being tested?
- Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2024to Jul 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
- Cryptogenic stroke (within the last six month) after full standard evaluation:
- Stroke detected by computed tomography (CT) or magnetic resonance imaging (MRI) that is not lacunar (lacunar is defined as a subcortical infarct in the distribution of the small, penetrating cerebral arteries whose largest dimension is ≤1.5 cm on CT or ≤2.0 cm on MRI diffusion images)
- Absence of extracranial or intracranial atherosclerosis causing ≥50 percent luminal stenosis of the artery supplying the area of ischemia
- No major-risk cardioembolic source of embolism (i.e., no permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumors, high-grade mitral valve stenosis, recent (within four weeks) myocardial infarction, left ventricular ejection fraction <30 percent, valvular vegetations, or infective endocarditis)
- No other specific cause of stroke identified (e.g., arteritis, dissection, migraine, vasospasm, drug abuse)
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- No paroxysmal atrial fibrillation in 72h of in-hospital ECG-monitoring, including at least one Holter- ECG for 24 hours.
- Cryptogenic TIA with definite cortical syndrome (aphasia, neglect or homonymous hemianopia) (within the last six month) after full standard evaluation (see above)
- Age: ≥40 yrs.
- At least one of the following risk factors:
- CHA2DS2VASc score ≥4
- Atrial runs
- Left atrial size > 45mm
- Left atrial appendage flow ≤ 0.2m/s
- No contraindication for anticoagulant therapy after acute phase of stroke
- Written informed consent by patient or authorized caregiver
Who cannot join
- Patient is not able to perform 1-lead ECG recording with smartwatch
- Patient possesses no smartphone (iOS version ≥10.0 or Android)
- Implanted pacemaker or cardioverter defibrillator (ICD)
- Pregnancy and breastfeeding period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Klinikum rechts der Isar, Technische Universität München
Munich, 81675
Silke Wunderlich, Dr. med., 0049(0)8941404606, silke.wunderlich@tum.de
Silke Wunderlich, Dr. med.
About this study
Official title: Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke - WATCH AFib A Prospective, Intraindividual-controlled, Multicenter Clinical Study
Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Thus, prolonged ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a smartwatch could lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy and may constitute a cost-effective, non-invasive, and broadly-available alternative to the current standard of care.
Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder.
Read more
Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an implanted event recorder as indicated by clinical standard, included patients receive a smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set to evaluate start of anticoagulation. The follow-up period will be six months. The study consists of four study visits: a baseline visit, two phone visits at one and three months, and an end of trial visit at six months.
Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity and specificity of AFib detection per patient after six months
Read the detailed description
Ischemic stroke is worldwide the second most frequent cause of death and disability and has a lifetime risk of approximately 25%. In the secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Cryptogenic stroke is defined as ischemic stroke for which no probable cause is found despite a full standard evaluation and comprises 25% of all ischemic strokes. Prolonged electrocardiogram (ECG) monitoring for 30 days to 6 months significantly increases the detection of occult paroxysmal AFib in cryptogenic stroke, which is present in 9 - 16%. Thus, prolonged ECG monitoring is likely to lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy.
Still, prolonged AFib screening after stroke is currently suboptimal due to a limitation of resources, loss to follow-up, invasiveness of procedures, and costs. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Sensitivity and specificity of AFib detection compared to ECG-based diagnosis is high (93-98% and 90-98%, respectively). Compared to implantable Event Recorders, smartwatch based AFib diagnosis in the general population exhibits a sensitivity of 97.5% for AFib episodes >1h and a sensitivity of 100% for AFib detection per patient.
The investigators hypothesize that AFib detection via smartwatch in patients suffering from cryptogenic transient ischemic attack (TIA) or ischemic stroke is accurate for AFib detection compared to an implantable Event Recorder and might therefore be a non-invasive, cost-effective, widely available alternative, which could potentially change the current standard of post-stroke care.
The primary objective is to assess whether AFib detection via smartwatch in patients suffering from cryptogenic TIA/ ischemic stroke is accurate in comparison to implantable Event Recorders. This will be assessed by sensitivity and specificity of AFib detection per patient after six months. The investigators aim on a comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis.
This is a prospective, intraindividual-controlled, multicenter clinical study.
The study population includes patients with cryptogenic TIA or ischemic stroke and known risk factors for the presence of paroxysmal AFib (see inclusion criteria; CHA2DS2VASc score ≥4, Atrial runs, Left atrial size > 45mm, Left atrial appendage flow ≤ 0.2m/s).
In addition to an implanted Event Recorder according to clinical standard, patients receive a smartwatch. Smartwatch- and Event Recorder-derived heart rhythm are daily uploaded and ana-lyzed by the cardiologists at the Cardiology Core Lab at the Department of Internal Medicine I, Klinikum rechts der Isar, Munich. The obtained data on cardiac arrhythmia will be assessable for each study site in consultation with the Cardiology Core Lab. In case of an arrhythmic event, the obtained data on duration, source of information (e.g., smartwatch PPG signal, smartwatch 1-lead ECG, Event Recorder) will be implemented in the eCRF by the Cardiology Core Lab.
In parallel, the study consists of a total of four visits. The baseline visit (Visit 0) may take place within the clinical setting of the acute stroke work up. A table containing a detailed plan of the data to be collected will be provided. Furtherly, the implementation and set-up of the smart-watch will take place within the baseline visit. A manual will be provided for each study center and patient to correctly set up and instruct on the usage of the smartwatch. The second and third visit (Visit 1, Visit 2) constitute phone-visits at one and three months with a tolerated time deviation of one week. The last visit at the end of the study (Visit 3) will be performed at six months with a tolerated time deviation of three weeks. This visit will take place at each pa-tient's study center. A table containing a detailed plan of the data to be collected will be pro-vided for each study center.
The first patient is planned to be included approximately in the third quarter of 2023 and the last patient approximately in the first quarter of 2025. Accordingly, the last patient will exit the study ('last patient last visit') approximately by the end of 2025.
The clinical study will be carried out in accordance with the study protocol and the principles of the Declaration of Helsinki by the World Medical Association and specific applicable national ethical and regulatory requirements.
All patients included in the clinical study will receive standard of care for cryptogenic TIA/ is-chemic stroke. The clinical study protocol does not interfere with generally accepted standards in post stroke care and local SOPs .The applied smartwatch is CE-certified as a medical device for AFib detection. As the study intervention consists in simply wearing a smartwatch (and phone visits are implemented at one and three months), we expect no safety risk for study partici-pants.
- Being tested
- Smartwatch
- Keywords
- Smartwatch, Ischemic stroke, atrial fibrillation
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmartwatchDevice
Smartwatch with PPG- and 1-lead ECG derived analysis of cardiac arrhythmia. Analysis will be performed centrally at the Cardiology Core Lab at the Klinikum Rechts der Isar.
| Study group | Role | What they receive |
|---|---|---|
| Application of Smartwatch | Experimental | Application of smartwatch in addition to an implanted event recorder. Follow-up of 6 months Receives: Device: Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of AFib Detection
To estimate and compare sensitivity and specificity for AFib detection per patient after six months (Comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis).
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Secondary outcomes (13)
To estimate and compare the positive and negative predictive values for AFib detection per patient
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity and specificity for AFib detection of the automated PPG-signal rhythm analysis
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity and specificity for the detection of any AFib episode
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity for the detection of AFib episodes >1 hour
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity and specificity of AFib detection per recorded/ per analyzable time (i.e., intervals in which the watch is actually worn/records an analyzable signal; per-protocol analysis)
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Specificity for episodes of sinus rhythms >1 hour
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Stroke and TIA recurrence within six months
Stroke or TIA recurrence in the clinical follop-up visits at 1, 3 and 6 months
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Subgroup analysis: accuracy in severely affected patients (i.e., National Institute of Health Stroke Scale (NIHSS) ≥8)
NIHSS: 0-42 points, a higher score refers to the presence of more stroke related symtpoms/ worse outcome
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: Acceptance and practicability of smartwatches for AFib detection
self-designed questionnaire
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: AFib burden/ patient
Duration of AFib episodes/ Duration of Sinus rhythm
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: relevance of AFib risk factors
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: AFib detection rates after one month and after six months and time to confirmed AFib diagnosis
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: count of AFib diagnoses
Measured: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start15 Oct 2024
- Primary completionMar 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, CryptogenicStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, intraindividual-controlled, multicenter clinical study.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005233
- Sponsor's protocol ID
- 20230726
- Acronym
- WATCH AFib
- Status last verified
- Nov 2024
- First submitted
- 1 Aug 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
PubMed 30879893Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov 20;342(8882):1255-62.
PubMed 7901582Hart RG, Pearce LA, Koudstaal PJ. Transient ischemic attacks in patients with atrial fibrillation: implications for secondary prevention: the European Atrial Fibrillation Trial and Stroke Prevention in Atrial Fibrillation III trial. Stroke. 2004 Apr;35(4):948-51. doi: 10.1161/01.STR.0000120741.34866.1D. Epub 2004 Feb 26.
PubMed 14988571Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7.
PubMed 24646875Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
PubMed 24963567Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.
PubMed 24963566Tsivgoulis G, Katsanos AH, Mac Grory B, Kohrmann M, Ricci BA, Tsioufis K, Cutting S, Krogias C, Schellinger PD, Campello AR, Cuadrado-Godia E, Gladstone DJ, Sanna T, Wachter R, Furie K, Alexandrov AV, Yaghi S. Prolonged Cardiac Rhythm Monitoring and Secondary Stroke Prevention in Patients With Cryptogenic Cerebral Ischemia. Stroke. 2019 Aug;50(8):2175-2180. doi: 10.1161/STROKEAHA.119.025169. Epub 2019 Jun 20.
PubMed 31216964Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
PubMed 31722151Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.
PubMed 29562087Dorr M, Nohturfft V, Brasier N, Bosshard E, Djurdjevic A, Gross S, Raichle CJ, Rhinisperger M, Stockli R, Eckstein J. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208. doi: 10.1016/j.jacep.2018.10.006. Epub 2018 Nov 28.
PubMed 30784691Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch Performance for the Detection and Quantification of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e006834. doi: 10.1161/CIRCEP.118.006834.
PubMed 31113234Afzal MR, Gunda S, Waheed S, Sehar N, Maybrook RJ, Dawn B, Lakkireddy D. Role of Outpatient Cardiac Rhythm Monitoring in Cryptogenic Stroke: A Systematic Review and Meta-Analysis. Pacing Clin Electrophysiol. 2015 Oct;38(10):1236-45. doi: 10.1111/pace.12688. Epub 2015 Aug 27.
PubMed 26172621Ding EY, CastanedaAvila M, Tran KV, Mehawej J, Filippaios A, Paul T, Otabil EM, Noorishirazi K, Han D, Saczynski JS, Barton B, Mazor KM, Chon K, McManus DD. Usability of a smartwatch for atrial fibrillation detection in older adults after stroke. Cardiovasc Digit Health J. 2022 Apr 18;3(3):126-135. doi: 10.1016/j.cvdhj.2022.03.003. eCollection 2022 Jun.
PubMed 35720675Poli S, Diedler J, Hartig F, Gotz N, Bauer A, Sachse T, Muller K, Muller I, Stimpfle F, Duckheim M, Steeg M, Eick C, Schreieck J, Gawaz M, Ziemann U, Zuern CS. Insertable cardiac monitors after cryptogenic stroke--a risk factor based approach to enhance the detection rate for paroxysmal atrial fibrillation. Eur J Neurol. 2016 Feb;23(2):375-81. doi: 10.1111/ene.12843. Epub 2015 Oct 16.
PubMed 26470854
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke - WATCH AFib A Prospective, Intraindividual-controlled, Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT06005233
- Acronym / sponsor ID
- WATCH AFib / 20230726
- Keywords
- Smartwatch, Ischemic stroke, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Aug 2023 (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.
Scientific Background: In secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Prolonged electrocardiogram (ECG) monitoring up to 6 months significantly increases detection of AFib in cryptogenic stroke. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Thus, prolonged ECG monitoring after cryptogenic ischemic stroke or transient ischemic attack (TIA) using a smartwatch could lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy and may constitute a cost-effective, non-invasive, and broadly-available alternative to the current standard of care.
Hypothesis: The investigators hypothesize that AFib detection via smartwatch in patients with cryptogenic TIA or ischemic stroke is accurate compared to an implantable event recorder.
Methods: The investigators introduce a prospective, intraindividual-controlled, multicentre clinical study in patients with cryptogenic ischemic stroke or TIA. In addition to an implanted event recorder as indicated by clinical standard, included patients receive a smartwatch for detection of AFib. ECG-data from smartwatches will be continuously monitored by two independent cardiologists. As soon as AFib is confirmed, a doctoral appointment is set to evaluate start of anticoagulation. The follow-up period will be six months. The study consists of four study visits: a baseline visit, two phone visits at one and three months, and an end of trial visit at six months.
Primary Objective: To compare smartwatch and event recorder based analysis for sensitivity and specificity of AFib detection per patient after six months
Detailed description
Ischemic stroke is worldwide the second most frequent cause of death and disability and has a lifetime risk of approximately 25%. In the secondary prevention of ischemic stroke, detection of atrial fibrillation (AFib) and subsequent anticoagulation therapy reduce the risk of recurrent stroke by approximately 60%. Cryptogenic stroke is defined as ischemic stroke for which no probable cause is found despite a full standard evaluation and comprises 25% of all ischemic strokes. Prolonged electrocardiogram (ECG) monitoring for 30 days to 6 months significantly increases the detection of occult paroxysmal AFib in cryptogenic stroke, which is present in 9 - 16%. Thus, prolonged ECG monitoring is likely to lead to a reduction of recurrent stroke by prompting adequate anticoagulation therapy.
Still, prolonged AFib screening after stroke is currently suboptimal due to a limitation of resources, loss to follow-up, invasiveness of procedures, and costs. Wearables like smartwatches have recently been shown to adequately detect AFib in the general population. Sensitivity and specificity of AFib detection compared to ECG-based diagnosis is high (93-98% and 90-98%, respectively). Compared to implantable Event Recorders, smartwatch based AFib diagnosis in the general population exhibits a sensitivity of 97.5% for AFib episodes >1h and a sensitivity of 100% for AFib detection per patient.
The investigators hypothesize that AFib detection via smartwatch in patients suffering from cryptogenic transient ischemic attack (TIA) or ischemic stroke is accurate for AFib detection compared to an implantable Event Recorder and might therefore be a non-invasive, cost-effective, widely available alternative, which could potentially change the current standard of post-stroke care.
The primary objective is to assess whether AFib detection via smartwatch in patients suffering from cryptogenic TIA/ ischemic stroke is accurate in comparison to implantable Event Recorders. This will be assessed by sensitivity and specificity of AFib detection per patient after six months. The investigators aim on a comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis.
This is a prospective, intraindividual-controlled, multicenter clinical study.
The study population includes patients with cryptogenic TIA or ischemic stroke and known risk factors for the presence of paroxysmal AFib (see inclusion criteria; CHA2DS2VASc score ≥4, Atrial runs, Left atrial size > 45mm, Left atrial appendage flow ≤ 0.2m/s).
In addition to an implanted Event Recorder according to clinical standard, patients receive a smartwatch. Smartwatch- and Event Recorder-derived heart rhythm are daily uploaded and ana-lyzed by the cardiologists at the Cardiology Core Lab at the Department of Internal Medicine I, Klinikum rechts der Isar, Munich. The obtained data on cardiac arrhythmia will be assessable for each study site in consultation with the Cardiology Core Lab. In case of an arrhythmic event, the obtained data on duration, source of information (e.g., smartwatch PPG signal, smartwatch 1-lead ECG, Event Recorder) will be implemented in the eCRF by the Cardiology Core Lab.
In parallel, the study consists of a total of four visits. The baseline visit (Visit 0) may take place within the clinical setting of the acute stroke work up. A table containing a detailed plan of the data to be collected will be provided. Furtherly, the implementation and set-up of the smart-watch will take place within the baseline visit. A manual will be provided for each study center and patient to correctly set up and instruct on the usage of the smartwatch. The second and third visit (Visit 1, Visit 2) constitute phone-visits at one and three months with a tolerated time deviation of one week. The last visit at the end of the study (Visit 3) will be performed at six months with a tolerated time deviation of three weeks. This visit will take place at each pa-tient's study center. A table containing a detailed plan of the data to be collected will be pro-vided for each study center.
The first patient is planned to be included approximately in the third quarter of 2023 and the last patient approximately in the first quarter of 2025. Accordingly, the last patient will exit the study ('last patient last visit') approximately by the end of 2025.
The clinical study will be carried out in accordance with the study protocol and the principles of the Declaration of Helsinki by the World Medical Association and specific applicable national ethical and regulatory requirements.
All patients included in the clinical study will receive standard of care for cryptogenic TIA/ is-chemic stroke. The clinical study protocol does not interfere with generally accepted standards in post stroke care and local SOPs .The applied smartwatch is CE-certified as a medical device for AFib detection. As the study intervention consists in simply wearing a smartwatch (and phone visits are implemented at one and three months), we expect no safety risk for study partici-pants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, intraindividual-controlled, multicenter clinical study.
| Arm | Type | Receives |
|---|---|---|
| Application of Smartwatch | Experimental | Device: SmartwatchApplication of smartwatch in addition to an implanted event recorder. Follow-up of 6 months |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Implanted Event Recorder with telemedicinal function (e.g., Biotronik BioMon 3m ProMRI HomeMon or similar)
- Cryptogenic stroke (within the last six month) after full standard evaluation:
- Cryptogenic TIA with definite cortical syndrome (aphasia, neglect or homonymous hemianopia) (within the last six month) after full standard evaluation (see above)
- Age: ≥40 yrs.
- At least one of the following risk factors:
Key exclusion criteria (4 listed)
- Patient is not able to perform 1-lead ECG recording with smartwatch
- Patient possesses no smartphone (iOS version ≥10.0 or Android)
- Implanted pacemaker or cardioverter defibrillator (ICD)
- Pregnancy and breastfeeding period
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 |
|---|---|---|
| SmartwatchSmartwatch with PPG- and 1-lead ECG derived analysis of cardiac arrhythmia. Analysis will be performed centrally at the Cardiology Core Lab at the Klinikum Rechts der Isar. | Device | Application of Smartwatch |
Primary outcome
Sensitivity and Specificity of AFib Detection
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
To estimate and compare sensitivity and specificity for AFib detection per patient after six months (Comparison of smartwatch based, continuous, automated, cardiologist supervised rhythm analysis of photoplethysmography (PPG)- signal and patient activated 1-lead ECG with Event Recorder based, continuous, automated ECG rhythm analysis).
13 secondary outcomes
To estimate and compare the positive and negative predictive values for AFib detection per patient
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity and specificity for AFib detection of the automated PPG-signal rhythm analysis
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity and specificity for the detection of any AFib episode
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity for the detection of AFib episodes >1 hour
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Sensitivity and specificity of AFib detection per recorded/ per analyzable time (i.e., intervals in which the watch is actually worn/records an analyzable signal; per-protocol analysis)
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Specificity for episodes of sinus rhythms >1 hour
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Stroke and TIA recurrence within six months
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Subgroup analysis: accuracy in severely affected patients (i.e., National Institute of Health Stroke Scale (NIHSS) ≥8)
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: Acceptance and practicability of smartwatches for AFib detection
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: AFib burden/ patient
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: relevance of AFib risk factors
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: AFib detection rates after one month and after six months and time to confirmed AFib diagnosis
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
Exploratory endpoint: count of AFib diagnoses
Time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months
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 13 Dec 2024.
- Background: PubMed 30879893GBD 2016 Neurology Collaborators. Global, regional, and national burden of neurological disorders, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 May;18(5):459-480. doi: 10.1016/S1474-4422(18)30499-X. Epub 2019 Mar 14.
- Background: PubMed 7901582Secondary prevention in non-rheumatic atrial fibrillation after transient ischaemic attack or minor stroke. EAFT (European Atrial Fibrillation Trial) Study Group. Lancet. 1993 Nov 20;342(8882):1255-62.
- Background: PubMed 14988571Hart RG, Pearce LA, Koudstaal PJ. Transient ischemic attacks in patients with atrial fibrillation: implications for secondary prevention: the European Atrial Fibrillation Trial and Stroke Prevention in Atrial Fibrillation III trial. Stroke. 2004 Apr;35(4):948-51. doi: 10.1161/01.STR.0000120741.34866.1D. Epub 2004 Feb 26.
- Background: PubMed 24646875Hart RG, Diener HC, Coutts SB, Easton JD, Granger CB, O'Donnell MJ, Sacco RL, Connolly SJ; Cryptogenic Stroke/ESUS International Working Group. Embolic strokes of undetermined source: the case for a new clinical construct. Lancet Neurol. 2014 Apr;13(4):429-38. doi: 10.1016/S1474-4422(13)70310-7.
- Background: PubMed 24963567Sanna T, Diener HC, Passman RS, Di Lazzaro V, Bernstein RA, Morillo CA, Rymer MM, Thijs V, Rogers T, Beckers F, Lindborg K, Brachmann J; CRYSTAL AF Investigators. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014 Jun 26;370(26):2478-86. doi: 10.1056/NEJMoa1313600.
- Background: PubMed 24963566Gladstone DJ, Spring M, Dorian P, Panzov V, Thorpe KE, Hall J, Vaid H, O'Donnell M, Laupacis A, Cote R, Sharma M, Blakely JA, Shuaib A, Hachinski V, Coutts SB, Sahlas DJ, Teal P, Yip S, Spence JD, Buck B, Verreault S, Casaubon LK, Penn A, Selchen D, Jin A, Howse D, Mehdiratta M, Boyle K, Aviv R, Kapral MK, Mamdani M; EMBRACE Investigators and Coordinators. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. doi: 10.1056/NEJMoa1311376.
- Background: PubMed 31216964Tsivgoulis G, Katsanos AH, Mac Grory B, Kohrmann M, Ricci BA, Tsioufis K, Cutting S, Krogias C, Schellinger PD, Campello AR, Cuadrado-Godia E, Gladstone DJ, Sanna T, Wachter R, Furie K, Alexandrov AV, Yaghi S. Prolonged Cardiac Rhythm Monitoring and Secondary Stroke Prevention in Patients With Cryptogenic Cerebral Ischemia. Stroke. 2019 Aug;50(8):2175-2180. doi: 10.1161/STROKEAHA.119.025169. Epub 2019 Jun 20.
- Background: PubMed 31722151Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
- Background: PubMed 29562087Tison GH, Sanchez JM, Ballinger B, Singh A, Olgin JE, Pletcher MJ, Vittinghoff E, Lee ES, Fan SM, Gladstone RA, Mikell C, Sohoni N, Hsieh J, Marcus GM. Passive Detection of Atrial Fibrillation Using a Commercially Available Smartwatch. JAMA Cardiol. 2018 May 1;3(5):409-416. doi: 10.1001/jamacardio.2018.0136.
- Background: PubMed 30784691Dorr M, Nohturfft V, Brasier N, Bosshard E, Djurdjevic A, Gross S, Raichle CJ, Rhinisperger M, Stockli R, Eckstein J. The WATCH AF Trial: SmartWATCHes for Detection of Atrial Fibrillation. JACC Clin Electrophysiol. 2019 Feb;5(2):199-208. doi: 10.1016/j.jacep.2018.10.006. Epub 2018 Nov 28.
- Background: PubMed 31113234Wasserlauf J, You C, Patel R, Valys A, Albert D, Passman R. Smartwatch Performance for the Detection and Quantification of Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2019 Jun;12(6):e006834. doi: 10.1161/CIRCEP.118.006834.
- Background: PubMed 26172621Afzal MR, Gunda S, Waheed S, Sehar N, Maybrook RJ, Dawn B, Lakkireddy D. Role of Outpatient Cardiac Rhythm Monitoring in Cryptogenic Stroke: A Systematic Review and Meta-Analysis. Pacing Clin Electrophysiol. 2015 Oct;38(10):1236-45. doi: 10.1111/pace.12688. Epub 2015 Aug 27.
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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 Smartwatch in people with Ischemic Stroke, Cryptogenic and Transient Ischemic Attack, run by Technical University of Munich at 1 site 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 16 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 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?
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 Silke Wunderlich, Dr.med (0049(0)8941404606, Silke.Wunderlich@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of AFib Detection (time frame: From baseline visit (V0) to the last follow-up at visit (V3) at six months). 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 NCT06005233, which also lists 14 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 13 Dec 2024.