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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ADVANCE-D: ATP Delivery for Painless ICD Therapy

Conditions
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Tachycardia, Ventricular, Ventricular Fibrillation

Intervention / Treatment
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* Device: Implantable Cardiac Defibrillator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 8 pulses<br>8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) | Device: Implantable Cardiac Defibrillator<br>* Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone<br>|
| Experimental: 15 pulses<br>15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT) | Device: Implantable Cardiac Defibrillator<br>* Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Percent Reduction in Shocks Delivered Per Patient for Treating FVT |  | one year | 
| Compare Likelihood of Syncopal Events Associated With FVT |  | one year | 
| Evaluate Different Possible Predictors of ATP Success |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ATP, Thachy, FVT