Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation
Study of Defibrillation Testing In Patients Undergoing Initial ICD Implantation
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.
Inclusion Criteria:

 -  Age ≥ 18 years

 -  Initial ICD implantation (single, dual, or CRT) for a standard Class I or Class II
 indication according to the ACC/AHA/HRS practice guidelines

 -  Anticipated life expectancy >6 months

 Exclusion Criteria:

 -  Contraindications to defibrillation testing as determined by the managing physician*

 -  ICD replacement implants

 -  Right-sided pectoral implants

 -  Abdominal implants

 -  Chronic oral amiodarone therapy (for >6 weeks and continued need for amiodarone)

 -  Inability to give informed consent

 -  Contraindications to defibrillation testing include the following: hemodynamic
 instability, LA thrombus, atrial fibrillation without adequate anticoagulation,
 LV thrombus, recent CVA or TIA, severe unrevascularized coronary artery disease
 or unstable angina, severe aortic stenosis, inotropic dependence, patient
 refusal, other patient-specific medical conditions that are deemed as
 contraindications, as determined by the implanting physician.