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

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.

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