Using smartwatches to detect atrial fibrillation after cryptogenic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.