Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.
The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed. The emulator is not a powered medical device. This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
induced tachy-arrhythmia to be terminated by ISSD emulator
Nemocnice Na Homolce
Prague, Czechia
Defibrillation Threshold (DFT)
lowest shock energy required to terminate tachy-arrhythmia
Time frame: immediately following induce tachy-arrhythmia
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.