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Completed

NCT Number: NCT00147277

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

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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Key information

Conditions

Tachycardia, Ventricular Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medtronic Italia SpA

Sesto San Giovanni, MI, 20099, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardiac Defibrillator

Device

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

Primary outcomes

  1. Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec)

    Time frame: one year

    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.

Secondary outcomes

  1. Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention

    Time frame: one year

  2. Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms

    Time frame: one year

  3. Percent Reduction in Shocks Delivered Per Patient for Treating FVT

    Time frame: one year

  4. Compare Likelihood of Syncopal Events Associated With FVT

    Time frame: one year

  5. Evaluate Different Possible Predictors of ATP Success

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

ADVANCE-D: ATP Delivery for Painless ICD Therapy

Acronym: ADVANCE_D

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Sep 7, 2005
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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