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

July 9, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

ADVANCE-D: ATP Delivery for Painless 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

925

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Sesto San Giovanni, MI, Italy, 20099
        • Medtronic Italia SpA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 8 pulses
8 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Device: Implantable Cardiac Defibrillator
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
Experimental: 15 pulses
15 pulses Anti-Tachycardia Pacing (ATP) delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
Device: Implantable Cardiac Defibrillator
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention
Time Frame: one year
one year
Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms
Time Frame: one year
one year
Percent Reduction in Shocks Delivered Per Patient for Treating FVT
Time Frame: one year
one year
Compare Likelihood of Syncopal Events Associated With FVT
Time Frame: one year
one year
Evaluate Different Possible Predictors of ATP Success
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Principal Investigator: Maurizio Lunati, Dr., Ospedale Niguarda Cà Granda - Milano
  • Principal Investigator: Riccardo Cappato, Dr., Istituto Policlinico S. Donato Milanese
  • Principal Investigator: Massimo Santini, Prof., San Filippo Neri - Roma
  • Principal Investigator: Angel Arenal, Dr., Hospital Gregorio Marañón, Madrid
  • Principal Investigator: Josè Luis Merino, Dr., Hospital Universitario La Paz
  • Principal Investigator: Arcadio Garcia-Alberola, Dr., Hospital Universitario Virgen de La Arrixaca
  • Principal Investigator: Johann Mermi, Dr., Clinic Center Dortmund
  • Principal Investigator: Pascal Defaye, Dr., University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimated)

September 7, 2005

Study Record Updates

Last Update Posted (Actual)

July 11, 2025

Last Update Submitted That Met QC Criteria

July 9, 2025

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 900AD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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