ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (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.
Inclusion Criteria:

 -  ICD indications (Class I-II A) according to the guidelines (patient with coronary
 artery disease [CAD] or non-CAD in primary or secondary ICD prevention)

 -  Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for
 FVT via VF

 Exclusion Criteria:

 -  Patient's life expectancy less than 1 year due to a non-cardiac chronic disease

 -  Patient on heart transplant list which is expected in < 1 year

 -  Patient's age less than 18 years

 -  ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)

 -  Unwillingness or inability to provide written informed consent

 -  Enrollment in, or intention to participate in, another clinical study during the
 course of this study

 -  Inaccessibility for follow-up at the study center

 -  Ventricular tachyarrhythmias associated with reversible causes

 -  Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients

 -  Other electrical implantable devices (neurostimulators, etc.)

 -  Mechanical tricuspid valve