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

Medtronic Cardiac Rhythm and Heart Failure526 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

526

Conditions

Tachycardia, Ventricular Ventricular Fibrillation

Interventions

Implantable Cardiac DefibrillatorDEVICE

Implantable cardiac defibrillator with programmable Fast Ventricular tachycardia detection (FVT) window

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medtronic Italia SpA

Sesto San Giovanni, Milan, Italy

Outcomes

Primary Outcomes

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.

Time frame: one year

Secondary Outcomes

Compare Efficacy of the First BiV and RV ATP to Terminate FVT

Time frame: one year

Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT

Time frame: one year

Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT

Time frame: one year

Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF

Time frame: one year

Data from ClinicalTrials.gov

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