ADVANCE-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

925 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2008-01-31

Brief Summary

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The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.

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Detailed Description

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Main objective: Compare \& quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to 12 months post randomisation in patients who are treated with ATP -8 pulses, 88% versus patients who are treated with ATP -15 pulses, 88%

Secondary objectives:

* Estimate the efficacy of ATP in successfully treating FVT episodes for patients in primary and secondary prevention
* Estimate acceleration rate or degeneration of ATP therapy for treating spontaneous FVT episodes in the ATP 15 vs 8 arm
* Compare the likelihood of syncopal events associated with spontaneous FVT episodes
* Estimate the percent reduction in number of shocks delivered per patient for treating spontaneous FVT episodes
* Evaluate different possible predictors of ATP success: VT rate, underlying disease, Anti-Arrhythmic Drugs (AAD), infarct zone, etc.

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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8 pulses

8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Group Type ACTIVE_COMPARATOR

Implantable Cardiac Defibrillator

Intervention Type DEVICE

Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

15 pulses

15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)

Group Type EXPERIMENTAL

Implantable Cardiac Defibrillator

Intervention Type DEVICE

Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

Interventions

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Implantable Cardiac Defibrillator

Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease \[CAD\] or non-CAD in primary or secondary ICD prevention)
* Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF

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
* ICD replacements and upgrading (single chamber \[SC\] ICD® dual chamber \[DC\] ICD)
* 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
* Ventricular tachyarrhythmias associated with reversible causes
* Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients
* Other electrical implantable devices (neurostimulators, etc.)
* Mechanical tricuspid valve

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No