Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-25 @ 2:52 AM
NCT ID:
NCT06005233
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06005233
Study Brief:
Protocol Section:
NCT06005233