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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2008-01-31

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.

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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

Conditions

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Tachycardia, Ventricular Ventricular Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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BiV

ATP therapies are delivered in both the ventricles

Group Type EXPERIMENTAL

Implantable Cardiac Defibrillator

Intervention Type DEVICE

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

RV

ATP delivered only in the right ventricle

Group Type ACTIVE_COMPARATOR

Implantable Cardiac Defibrillator

Intervention Type DEVICE

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

Interventions

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Implantable Cardiac Defibrillator

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

Intervention Type DEVICE

Other Intervention Names

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ICD

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No