Skip to main content
OpenTrials
Completed

NCT Number: NCT00617175

Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital St-Joseph, Gilly, Belgium

Loading trial locations.

About this study

Primary Objective:

The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities.

Secondary Objectives:

  • Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes.
  • Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study.
  • Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.
  • Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).
  • Describe the economic impact and the quality of life consequences.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
  • Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.

Exclusion criteria

  • ICD replacements and upgrading.
  • Brugada Syndrome, Long QT and HCM patients
  • Ventricular tachyarrhythmia associated with reversible cause.
  • Other electrical implantable devices (Neurostimulators, etc.).
  • Subject's life expectancy less than 1 year.
  • Subject on heart transplant list which is expected in less than 1 year.
  • Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
  • Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
  • Unwillingness or inability to provide written informed consent.
  • Enrolment in, or intention to participate in, another clinical trial.
  • Inaccessibility to come to the study center for the follow-up visits.
  • Mechanical tricuspid valve.

Treatment and study plan

Implantable defibrillator

Device

Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia

Primary outcomes

  1. For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.

    Time frame: From enrollment to study completion or exit whichever occured first

    for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.

    The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times * 100.

Secondary outcomes

  1. Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.

    Time frame: end of study

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

Acronym: ADVANCEIII

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Feb 15, 2008
Registry last updated
Jul 2, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.