Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Automatic external cardioverter defibrillator that monitors patients at risk for SCA and provides a therapeutic shock if needed.
Nemocnice Na Homolce Hospital
Prague, Czechia
Clinical Effectiveness of the Jewel
The count of participants with successful single shock terminations of life-threatening VT or VF. (The endpoint would be achieved if the lower confidence limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at one of three testing points.)
Time frame: Immediately following defibrillation with the study device.
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