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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Ventricular Fibrillation; Tachycardia, Ventricular

Treatments: Device: Implantable Cardiac Defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00147277

900AD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 925 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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925 participants in 2 patient groups

8 pulses

Active Comparator group

Description:

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

Treatment:

Device: Implantable Cardiac Defibrillator

15 pulses

Experimental group

Description:

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

Treatment:

Device: Implantable Cardiac Defibrillator