Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
NCT ID: NCT00617175
Last Updated: 2025-07-02
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1902 participants
INTERVENTIONAL
2008-03-31
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
NCT00147277
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
NCT00147290
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction
NCT00673842
Acute Defibrillation Study
NCT02227121
Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients
NCT01169246
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Long NID
Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
Short NID
Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jorg O. Schwab, MD
Role: STUDY_CHAIR
University of Bonn, Bonn, Germany
Maurizio Gasparini, MD
Role: PRINCIPAL_INVESTIGATOR
Humanitas Hospital, Milano Italy
Maurizio Lunati, MD
Role: PRINCIPAL_INVESTIGATOR
Niguarda Hospital, Milano, Italy
Bernd Lemke, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Lüdenscheid, Lüdenscheid, Germany
João Sousa, MD
Role: PRINCIPAL_INVESTIGATOR
H. Santa Maria - Lisbon - Portugal
Andrzej Okreglicki, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cape Town, Cape Town, South Africa
Angel Arenal, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Gregorio Marañón, Madrid, Spain
Maurits Wijffels, MD
Role: PRINCIPAL_INVESTIGATOR
St. Antonius hospital - NIEUWEGEIN, The Netherlands
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital St-Joseph
Gilly, , Belgium
CHU Brugmann
Laken, , Belgium
CHR La Citadelle Liege
Liège, , Belgium
CHR Namur
Namur, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
KAS Gentofte
Hellerup, , Denmark
Odense Universitets Hospital
Odense, , Denmark
Turku University Central Hospital
Turku, , Finland
Hôpital Michalon- CHU Grenoble
Grenoble, , France
CHU Nantes - Hôpital Guillaume et René Laënnec
Nantes, , France
NCN Nantes
Nantes, , France
Hopital de la Pitie Salpetriere
Paris, , France
Centre Hospitalier de Pau
Pau, , France
CHU Hôpital de Pontchaillou Rennes
Rennes, , France
CH Rangueil Toulouse
Toulouse, , France
Clinique Pasteur
Toulouse, , France
RWTH Aachen
Aachen, , Germany
University of Bonn
Bonn, , Germany
Kardiologisches Zentrum an der Klinik Rotes Kreuz
Frankfurt am Main, , Germany
SRH Wald-Klinikum Gera gGmbH
Gera, , Germany
Universitätskliniken des Saarlandes
Homburg, , Germany
Klinikum Lüdenscheid
Lüdenscheid, , Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg
Quedlinburg, , Germany
Universität Rostock- Medizinische Fakultät
Rostock, , Germany
Diakoniekrankenhaus Rotenburg
Rotenburg (Wümme), , Germany
Semmelweis University AOK
Budapest, , Hungary
Zala County Hospital
Zalaegerszeg, , Hungary
Presidio Ospedaliero di Venere
Carbonara, Bari, Italy
Azienda.Ospedaliera.G.M. Lancisi
Ancona, , Italy
Azienda Ospedaliera G. Rummo
Benevento, , Italy
Cliniche Gavazzeni
Bergamo, , Italy
Stab. Ospedaliero Di Summa-Perrino - Brindisi
Brindisi, , Italy
Casa di Cura Mater Domini
Castellanza, , Italy
Ospedale Pugliese e Ciaccio
Catanzaro, , Italy
A.O. Santa Croce e Carle
Cuneo, , Italy
Ente Ospedaliero Ospedali Galliera - Genova
Genova, , Italy
Ospedale Maggiore di Lodi
Lodi, , Italy
Istituto Ca' Granda-Niguarda
Milan, , Italy
San Carlo Borromeo
Milan, , Italy
Nuovo Osp. Civile S. Agostino
Modena, , Italy
P.O. di Montebelluna
Montebelluna, , Italy
Ospedale S. Giacomo
Novi Ligure, , Italy
Policlinico S. Matteo
Pavia, , Italy
Osp. S. Maria degli Angeli - Pordenone
Pordenone, , Italy
Ospedale Misericordia e Dolce
Prato, , Italy
Azienda Complesso Ospedaliero San Filippo Neri
Roma, , Italy
Ospedale Sandro Pertini
Roma, , Italy
Ospedale Sant Eugenio
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Osp. S. Giovanni di Dio e Ruggi dAragona
Salerno, , Italy
AZ. Osp. Ordine Mauriziano
Torino, , Italy
A.O. S.Maria della Misericordia
Udine, , Italy
ULSS N.6 S. Bortolo - Vicenza
Vicenza, , Italy
Medisch Spectrum Twente
Enschede, , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, , Netherlands
Zoz Mswia
Bialystok, , Poland
Hospital Garcia Orta, SA
Almada, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Hospital de Santa Marta
Lisbon, , Portugal
Hospital Geral de Santo António
Porto, , Portugal
Tyumen Cardiology Center
Tyumen, , Russia
King Fahd Armed Forces Hospital
Jeddah, , Saudi Arabia
King Khalid Univ. Hospital - King Saud University
Riyadh, , Saudi Arabia
Bloemfontein Medi-Clinic
Bloemfontein, , South Africa
Christiaan Barnard Memorial Hospital
Cape Town, , South Africa
University of Cape Town - Groote Schuur Hospital
Cape Town, , South Africa
Vincent Pallotti Hospital
Cape Town, , South Africa
Milpark Hospital
Johannesburg, , South Africa
Sunninghill Hospital
Johannesburg, , South Africa
UNITAS Hospital
Pretoria, , South Africa
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital de Basurto - Bilbao
Bilbao, , Spain
Hospital General Yagüe
Burgos, , Spain
Hospital General San Pedro de Alcantara
Cáceres, , Spain
Hospital General de Ciudad Real
Ciudad Real, , Spain
Hospital de Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
H. Ramón y Cajal
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Clinico de Malaga - Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Son Dureta
Palma Mallorca, , Spain
Hospital Universitario de San Juan
Sant Joan d'Alacant, , Spain
Hospital Ntra. Sra. de la Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, , Spain
Hospital Virgen de La Salud
Toledo, , Spain
Hospital Arnau de Vilanova
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Chuvi-Xeral-Cíes
Vigo, , Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Landolina M, Boriani G, Biffi M, Cattafi G, Capucci A, Dello Russo A, Facchin D, Rordorf R, Sagone A, Del Greco M, Morani G, Nicolis D, Meloni S, Grammatico A, Gasparini M. Determinants of worse prognosis in patients with cardiac resynchronization therapy defibrillators. Are ventricular arrhythmias an adjunctive risk factor? J Cardiovasc Med (Hagerstown). 2022 Jan 1;23(1):42-48. doi: 10.2459/JCM.0000000000001236.
Gasparini M, Kloppe A, Lunati M, Varma N, Martinez-Ferrer JB, Hersi A, Gulaj M, Wijffels MCEF, Arenal A, Mangoni di Santo Stefano L, Proclemer A. Sex differences in implantable cardiac defibrillator therapy according to arrhythmia detection times. Heart. 2020 Apr;106(7):520-526. doi: 10.1136/heartjnl-2019-315650. Epub 2019 Dec 11.
Gasparini M, Lunati MG, Proclemer A, Arenal A, Kloppe A, Martinez Ferrer JB, Hersi AS, Gulaj M, Wijffels MCE, Santi E, Manotta L, Varma N. Long Detection Programming in Single-Chamber Defibrillators Reduces Unnecessary Therapies and Mortality: The ADVANCE III Trial. JACC Clin Electrophysiol. 2017 Nov;3(11):1275-1282. doi: 10.1016/j.jacep.2017.05.001. Epub 2017 May 31.
Gasparini M, Kloppe A, Lunati M, Anselme F, Landolina M, Martinez-Ferrer JB, Proclemer A, Morani G, Biffi M, Ricci R, Rordorf R, Mangoni L, Manotta L, Grammatico A, Leyva F, Boriani G. Atrioventricular junction ablation in patients with atrial fibrillation treated with cardiac resynchronization therapy: positive impact on ventricular arrhythmias, implantable cardioverter-defibrillator therapies and hospitalizations. Eur J Heart Fail. 2018 Oct;20(10):1472-1481. doi: 10.1002/ejhf.1117. Epub 2017 Dec 18.
Kloppe A, Proclemer A, Arenal A, Lunati M, Martinez Ferrer JB, Hersi A, Gulaj M, Wijffels MC, Santi E, Manotta L, Mangoni L, Gasparini M. Efficacy of long detection interval implantable cardioverter-defibrillator settings in secondary prevention population: data from the Avoid Delivering Therapies for Nonsustained Arrhythmias in ICD Patients III (ADVANCE III) trial. Circulation. 2014 Jul 22;130(4):308-14. doi: 10.1161/CIRCULATIONAHA.114.009468. Epub 2014 May 16.
Gasparini M, Proclemer A, Klersy C, Kloppe A, Lunati M, Ferrer JB, Hersi A, Gulaj M, Wijfels MC, Santi E, Manotta L, Arenal A. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA. 2013 May 8;309(18):1903-11. doi: 10.1001/jama.2013.4598.
Schwab JO, Gasparini M, Lunati M, Proclemer A, Kaup B, Santi E, Ligorio G, Klersy C, DE Sousa J, Okreglicki A, Arenal A, Wijffels M, Lemke B. Avoid delivering therapies for nonsustained fast ventricular tachyarrhythmia in patients with implantable cardioverter/defibrillator: the ADVANCE III Trial. J Cardiovasc Electrophysiol. 2009 Jun;20(6):663-6. doi: 10.1111/j.1540-8167.2008.01415.x. Epub 2009 Jan 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADVANCE III
Identifier Type: -
Identifier Source: secondary_id
ADVANCE III
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.