Smartwatches for Detection of Atrial Fibrillation (AFib) in Secondary Prevention of Cryptogenic Stroke

Launched by TECHNICAL UNIVERSITY OF MUNICH · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether smartwatches can accurately detect a heart condition called atrial fibrillation (AFib) in patients who have had a type of stroke known as cryptogenic stroke or transient ischemic attack (TIA). Detecting AFib is important because it can help prevent future strokes by allowing doctors to start blood-thinning medication. In this study, participants will wear a smartwatch alongside a standard heart monitor implanted in their bodies. The researchers will compare the results from both devices to see how well the smartwatch performs in identifying AFib.

To be eligible for the trial, participants should be at least 40 years old and have had a cryptogenic stroke or TIA within the past six months, without any clear cause for that stroke. They must also have certain risk factors for AFib. Participants can expect to have four study visits over six months, including phone check-ins and an end-of-study appointment. This trial offers a chance for patients to use a modern, non-invasive tool for heart monitoring, which could lead to better care and prevention of future strokes.

Gender

ALL

Eligibility 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