Ventricular Fibrillation Clinical Trial
Official title:
ADVANCE CRT - D: ATP Delivery for Painless ICD Therapy
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in
patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I
or IIA indication for ICD implantation.
The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated
in a prospective, controlled and randomized study.
Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to
terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the
right ventricle (RV) only versus both ventricles (BiV) resulting in a 10 % difference in
favour of BIV ATP
Secondary objectives:
- Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate fast
ventricular tachycardia (FVT)
- Compare efficacy of the first BiV and RV ATP (Burst, 8 pulses, 88 %) to terminate slow
ventricular tachycardia (slow VT)
- Compare efficacy of BiV and RV ATP (all ATP therapies) to terminate slow ventricular
tachycardia (slow VT)
- Determine the rate of both FVT and VT episodes which are accelerated or degenerates
into VF
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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