Ventricular Fibrillation Clinical Trial
Official title:
ADVANCE-D: ATP Delivery for Painless ICD Therapy
The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.
Main objective: Compare & quantify efficacy of two different sequences of burst ATP
strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of
240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with
ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%
Secondary objectives:
- Estimate the efficacy of ATP in successfully treating FVT episodes for patients in
primary and secondary prevention
- Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT
episodes in the ATP 15 vs 8 arm
- Compare the likelihood of syncopal events associated with spontaneous FVT episodes
- Estimate the percent reduction in number of shocks delivered per patient for treating
spontaneous FVT episodes
- Evaluate different possible predictors of ATP success: VT rate, underlying disease,
Anti-Arrhythmic Drugs (AAD), infarct zone, etc.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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