Using smartwatches to detect atrial fibrillation after cryptogenic stroke
Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke - WATCH AFib A Prospective, Intraindividual-controlled, Multicenter Clinical Study
NA · Technical University of Munich · NCT06005233
This study is testing if smartwatches can help find atrial fibrillation in people who have had a stroke with no known cause, to prevent future strokes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Technical University of Munich (other) |
| Locations | 1 site (Munich) |
| Trial ID | NCT06005233 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of smartwatches in detecting atrial fibrillation (AFib) in patients who have experienced a cryptogenic stroke or transient ischemic attack (TIA). By utilizing prolonged ECG monitoring through smartwatches, the study seeks to improve the detection rates of AFib, which is crucial for preventing recurrent strokes. The methodology involves comparing the accuracy of smartwatch-based AFib detection to that of implantable event recorders. The goal is to provide a cost-effective and non-invasive alternative to current monitoring practices.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have experienced a cryptogenic stroke within the last six months and have an implanted event recorder.
Not a fit: Patients with known major-risk cardioembolic sources or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of recurrent strokes in patients by enabling timely anticoagulation therapy.
How similar studies have performed: Other studies have shown promising results with wearable technology for AFib detection, indicating that this approach is both novel and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) * 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 Exclusion Criteria: * 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
Where this trial is running
Munich
- Klinikum rechts der Isar, Technische Universität München — Munich, Germany (RECRUITING)
Study contacts
- Study coordinator: Silke Wunderlich, Dr.med
- Email: Silke.Wunderlich@tum.de
- Phone: 0049(0)8941404606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Cryptogenic, Transient Ischemic Attack, Atrial Fibrillation, Smartwatch, Ischemic stroke, atrial fibrillation