Ventricular Arrhythmias Clinical Trial
Official title:
"Test-No Test" Implantable Cardioverter Defibrillator Pilot Study (TNT-ICD)
The primary objective of this study is to compare the composite outcome of total mortality and operative complications in patients who do not undergo defibrillation testing to those who do undergo defibrillation testing at the time of initial ICD implantation.
Implantable cardioverter-defibrillators (ICDs) are the most effective treatment for the
primary and secondary prevention of sudden cardiac death (SCD). At the time of ICD
implantation, ventricular fibrillation (VF) is typically induced to demonstrate effective
arrhythmia termination by the implanted device. Although defibrillation threshold (DFT)
testing with induction of VF at time of ICD insertion is currently considered the "standard
of care," and instructions for usage of devices approved by the Food and Drug Administration
(FDA) include labeling with DFT testing, the value of defibrillation testing with modern-day
devices has been questioned. Defibrillation testing can be associated with serious
complications and may add to the cost of the procedure.
It is hypothesized that patients who do not undergo defibrillation testing will have
outcomes similar to those who do undergo defibrillation testing at the time of initial
implantation. This pilot study is being performed to determine the feasibility of performing
a larger, multi-center clinical trial with longer follow-up to investigate whether or not
defibrillation testing will have any impact on overall mortality, implant complications, or
long-term first shock efficacy during clinical follow-up.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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