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

Phase 4

Completed

Brief Summary: 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: 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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
BiV	Implantable Cardiac Defibrillator	ATP therapies are delivered in both the ventricles
RV	Implantable Cardiac Defibrillator	ATP delivered only in the right ventricle

Primary Outcome Measures

Name	Time	Method
Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia.	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
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