ASSURE WCD Clinical Evaluation - Detection and Safety Study (ACE-DETECT)
A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).
• Males or females, age ≥ 18 years
• Patients with an active Implantable Cardioverter Defibrillator (ICD)
• Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography
• Able and willing to provide written informed consent before undergoing any study-related procedures