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

June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure

ADVANCE III: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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:

  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.
  2. 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.
  3. Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.
  4. Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).
  5. Describe the economic impact and the quality of life consequences.

Study Type

Interventional

Enrollment (Actual)

1902

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

  • Belgium
      • Gilly, Belgium
        • Hopital St-Joseph
      • Laken, Belgium
        • CHU Brugmann
      • Liege, Belgium
        • CHR La Citadelle Liege
      • Namur, Belgium
        • CHR Namur
      • Sint-Niklaas, Belgium
        • AZ Nikolaas
  • Denmark
      • Hellerup, Denmark
        • KAS Gentofte
      • Odense, Denmark
        • Odense Universitets Hospital
  • Finland
      • Turku, Finland
        • Turku University Central Hospital
  • France
      • Grenoble, France
        • Hôpital Michalon- CHU Grenoble
      • Nantes, France
        • CHU Nantes - Hôpital Guillaume et René Laënnec
      • Nantes Cedex 2, France
        • NCN Nantes
      • Paris, France
        • Hôpital de la Pitié Salpêtrière
      • Pau, France
        • Centre Hospitalier de Pau
      • Rennes, France
        • CHU Hôpital de Pontchaillou Rennes
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • CH Rangueil Toulouse
  • Germany
      • Aachen, Germany
        • RWTH Aachen
      • Bonn, Germany
        • University of Bonn
      • Frankfurt am Main, Germany
        • Kardiologisches Zentrum an der Klinik Rotes Kreuz
      • Gera, Germany
        • SRH Wald-Klinikum Gera gGmbH
      • Homburg, Germany
        • Universitätskliniken des Saarlandes
      • Lüdenscheid, Germany
        • Klinikum Lüdenscheid
      • Quedlinburg, Germany
        • Klinikum Dorothea Christiane Erxleben Quedlinburg
      • Rostock, Germany
        • Universität Rostock- Medizinische Fakultät
      • Rotenburg, Germany
        • Diakoniekrankenhaus Rotenburg
  • Hungary
      • Budapest, Hungary
        • Semmelweis University AOK
      • Zalaegerszeg, Hungary
        • Zala County Hospital
  • Italy
      • Ancona, Italy
        • Azienda.Ospedaliera.G.M. Lancisi
      • Benevento, Italy
        • Azienda Ospedaliera G. Rummo
      • Bergamo, Italy
        • Cliniche Gavazzeni
      • Brindisi, Italy
        • Stab. Ospedaliero Di Summa-Perrino - Brindisi
      • Castellanza, Italy
        • Casa di Cura Mater Domini
      • Catanzaro, Italy
        • Ospedale Pugliese e Ciaccio
      • Cuneo, Italy
        • A.O. Santa Croce e Carle
      • Genova, Italy
        • Ente Ospedaliero Ospedali Galliera - Genova
      • Lodi, Italy
        • Ospedale Maggiore di Lodi
      • Milano, Italy
        • Istituto Ca' Granda-Niguarda
      • Milano, Italy
        • San Carlo Borromeo
      • Modena, Italy
        • Nuovo Osp. Civile S. Agostino
      • Montebelluna, Italy
        • P.O. di Montebelluna
      • Novi Ligure, Italy
        • Ospedale S. Giacomo
      • Pavia, Italy
        • Policlinico S. Matteo
      • Pordenone, Italy
        • Osp. S. Maria degli Angeli - Pordenone
      • Prato, Italy
        • Ospedale Misericordia e Dolce
      • Roma, Italy
        • Ospedale Sandro Pertini
      • Roma, Italy
        • Azienda Complesso Ospedaliero San Filippo Neri
      • Roma, Italy
        • Ospedale Sant Eugenio
      • Rozzano, Italy
        • Istituto Clinico Humanitas
      • Salerno, Italy
        • Osp. S. Giovanni di Dio e Ruggi dAragona
      • Torino, Italy
        • AZ. Osp. Ordine Mauriziano
      • Udine, Italy
        • A.O. S.Maria della Misericordia
      • Vicenza, Italy
        • ULSS N.6 S. Bortolo - Vicenza
    • Bari
      • Carbonara, Bari, Italy
        • Presidio Ospedaliero di Venere
  • Netherlands
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Nieuwegein, Netherlands
        • St. Antonius Ziekenhuis Nieuwegein
  • Poland
      • Bialystok, Poland
        • Zoz Mswia
  • Portugal
      • Almada, Portugal
        • Hospital Garcia Orta, SA
      • Lisboa, Portugal
        • Hospital de Santa Maria
      • Lisboa, Portugal
        • Hospital de Santa Marta
      • Porto, Portugal
        • Hospital Geral de Santo Antonio
  • Russian Federation
      • Tyumen, Russian Federation
        • Tyumen Cardiology Center
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Fahd Armed Forces Hospital
      • Riyadh, Saudi Arabia
        • King Khalid Univ. Hospital - King Saud University
  • South Africa
      • Bloemfontein, South Africa
        • Bloemfontein Medi-Clinic
      • Cape Town, South Africa
        • Christiaan Barnard Memorial Hospital
      • Cape Town, South Africa
        • University of Cape Town - Groote Schuur Hospital
      • Cape Town, South Africa
        • Vincent Pallotti Hospital
      • Johannesburg, South Africa
        • Milpark Hospital
      • Johannesburg, South Africa
        • Sunninghill Hospital
      • Pretoria, South Africa
        • Unitas Hospital
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante
      • Bilbao, Spain
        • Hospital de Basurto - Bilbao
      • Burgos, Spain
        • Hospital General Yague
      • Caceres, Spain
        • Hospital General San Pedro de Alcantara
      • Ciudad Real, Spain
        • Hospital General de Ciudad Real
      • Donostia-San Sebastian, Spain
        • Hospital de Donostia
      • Granada, Spain
        • Hospital Universitario Virgen de las Nieves
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • H. Ramón y Cajal
      • Madrid, Spain
        • Hospital Puerta de Hierro Majadahonda
      • Malaga, Spain
        • Hospital Clinico de Malaga - Virgen de la Victoria
      • Palma Mallorca, Spain
        • Hospital Universitario Son Dureta
      • San Juan de Alicante, Spain
        • Hospital Universitario de San Juan
      • Santa Cruz de Tenerife, Spain
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Spain
        • Hospital Ntra. Sra. de la Candelaria
      • Toledo, Spain
        • Hospital Virgen de la Salud
      • Valencia, Spain
        • Hospital Arnau De Vilanova
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
      • Vigo, Spain
        • Chuvi-Xeral-Cíes
      • Vitoria / Gasteiz, Spain
        • Hospital de Txagorritxu

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:

  • 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.

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
Experimental: Long NID
Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
Device: Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
Device: Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
Active Comparator: Short NID
Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
Device: Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
Device: Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to study completion or exit whichever occured first

Secondary Outcome Measures

Outcome Measure
Time Frame
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
end of study

Collaborators and Investigators

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Chair: Jorg O. Schwab, MD, University of Bonn, Bonn, Germany
  • Principal Investigator: Maurizio Gasparini, MD, Humanitas Hospital, Milano Italy
  • Principal Investigator: Maurizio Lunati, MD, Niguarda Hospital, Milano, Italy
  • Principal Investigator: Bernd Lemke, MD, Klinikum Lüdenscheid, Lüdenscheid, Germany
  • Principal Investigator: João Sousa, MD, H. Santa Maria - Lisbon - Portugal
  • Principal Investigator: Andrzej Okreglicki, MD, University of Cape Town, Cape Town, South Africa
  • Principal Investigator: Angel Arenal, MD, Hospital Gregorio Marañón, Madrid, Spain
  • Principal Investigator: Maurits Wijffels, MD, St. Antonius hospital - NIEUWEGEIN, The Netherlands

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, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

February 4, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimated)

February 15, 2008

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADVANCE III

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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