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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Ventricular Fibrillation; Tachycardia, Ventricular

Treatments: Device: Implantable Cardiac Defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147290

400ACRT

Details and patient eligibility

About

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.

Full 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

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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526 participants in 2 patient groups

BiV

Experimental group

Description:

ATP therapies are delivered in both the ventricles

Treatment:

Device: Implantable Cardiac Defibrillator

RV

Active Comparator group

Description:

ATP delivered only in the right ventricle

Treatment:

Device: Implantable Cardiac Defibrillator