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

Phase 4

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
8 pulses	Implantable Cardiac Defibrillator	8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
15 pulses	Implantable Cardiac Defibrillator	15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Primary Outcome Measures

Name	Time	Method
Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)	one year	Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients.

Secondary Outcome Measures

Name	Time	Method
Percent Reduction in Shocks Delivered Per Patient for Treating FVT	one year
Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention	one year
Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms	one year
Compare Likelihood of Syncopal Events Associated With FVT	one year
Evaluate Different Possible Predictors of ATP Success	one year