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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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ADVANCE CRT - 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: CRT + ICD indications (Class I-IIA) according to the guidelines Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD 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 Replacements and upgrades Epicardial lead Mechanical tricuspid valve Ventricular Tachyarrhythmias associated with reversible causes 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

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 |
| --- | --- |
| Experimental: BiV<br>ATP therapies are delivered in both the ventricles | Device: Implantable Cardiac Defibrillator<br>* Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window<br>* Other names: ICD;|
| Active Comparator: RV<br>ATP delivered only in the right ventricle | Device: Implantable Cardiac Defibrillator<br>* Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window<br>* Other names: ICD;|

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 (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. | 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 |
| --- | --- | --- |
| Compare Efficacy of the First BiV and RV ATP to Terminate FVT |  | one year | 
| Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT |  | one year | 
| Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT |  | one year | 
| Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ATP, Tachycardia, CRT-D