Clinical trial NCT00617175: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Official title: ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Disease
Keywords: Implantable Cardiac Defibrillator
therapies reduction
Shocks
Quality of Life
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 1902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.
timeFrame: From enrollment to study completion or exit whichever occured first
Secondary outcomes:
measure: 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.
timeFrame: end of study
Other outcomes:
Locations:
city: Gilly
country: Belgium
facility: Hopital St-Joseph
city: Laken
country: Belgium
facility: CHU Brugmann
city: Liege
country: Belgium
facility: CHR La Citadelle Liege
city: Namur
country: Belgium
facility: CHR Namur
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas
city: Hellerup
country: Denmark
facility: KAS Gentofte
city: Odense
country: Denmark
facility: Odense Universitets Hospital
city: Turku
country: Finland
facility: Turku University Central Hospital
city: Grenoble
country: France
facility: Hôpital Michalon- CHU Grenoble
city: Nantes Cedex 2
country: France
facility: NCN Nantes
city: Nantes
country: France
facility: CHU Nantes - Hôpital Guillaume et René Laënnec
city: Paris
country: France
facility: Hopital de la Pitie Salpetriere
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Rennes
country: France
facility: CHU Hôpital de Pontchaillou Rennes
city: Toulouse
country: France
facility: CH Rangueil Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Aachen
country: Germany
facility: RWTH Aachen
city: Bonn
country: Germany
facility: University of Bonn
city: Frankfurt am Main
country: Germany
facility: Kardiologisches Zentrum an der Klinik Rotes Kreuz
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera gGmbH
city: Homburg
country: Germany
facility: Universitätskliniken des Saarlandes
city: Lüdenscheid
country: Germany
facility: Klinikum Lüdenscheid
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben Quedlinburg
city: Rostock
country: Germany
facility: Universität Rostock- Medizinische Fakultät
city: Rotenburg
country: Germany
facility: Diakoniekrankenhaus Rotenburg
city: Budapest
country: Hungary
facility: Semmelweis University AOK
city: Zalaegerszeg
country: Hungary
facility: Zala County Hospital
city: Carbonara
country: Italy
facility: Presidio Ospedaliero di Venere
state: Bari
city: Ancona
country: Italy
facility: Azienda.Ospedaliera.G.M. Lancisi
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
city: Bergamo
country: Italy
facility: Cliniche Gavazzeni
city: Brindisi
country: Italy
facility: Stab. Ospedaliero Di Summa-Perrino - Brindisi
city: Castellanza
country: Italy
facility: Casa di Cura Mater Domini
city: Catanzaro
country: Italy
facility: Ospedale Pugliese e Ciaccio
city: Cuneo
country: Italy
facility: A.O. Santa Croce e Carle
city: Genova
country: Italy
facility: Ente Ospedaliero Ospedali Galliera - Genova
city: Lodi
country: Italy
facility: Ospedale Maggiore di Lodi
city: Milano
country: Italy
facility: Istituto Ca' Granda-Niguarda
city: Milano
country: Italy
facility: San Carlo Borromeo
city: Modena
country: Italy
facility: Nuovo Osp. Civile S. Agostino
city: Montebelluna
country: Italy
facility: P.O. di Montebelluna
city: Novi Ligure
country: Italy
facility: Ospedale S. Giacomo
city: Pavia
country: Italy
facility: Policlinico S. Matteo
city: Pordenone
country: Italy
facility: Osp. S. Maria degli Angeli - Pordenone
city: Prato
country: Italy
facility: Ospedale Misericordia e Dolce
city: Roma
country: Italy
facility: Azienda Complesso Ospedaliero San Filippo Neri
city: Roma
country: Italy
facility: Ospedale Sandro Pertini
city: Roma
country: Italy
facility: Ospedale Sant Eugenio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Salerno
country: Italy
facility: Osp. S. Giovanni di Dio e Ruggi dAragona
city: Torino
country: Italy
facility: AZ. Osp. Ordine Mauriziano
city: Udine
country: Italy
facility: A.O. S.Maria della Misericordia
city: Vicenza
country: Italy
facility: ULSS N.6 S. Bortolo - Vicenza
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Bialystok
country: Poland
facility: Zoz Mswia
city: Almada
country: Portugal
facility: Hospital Garcia Orta, SA
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria
city: Lisboa
country: Portugal
facility: Hospital de Santa Marta
city: Porto
country: Portugal
facility: Hospital Geral de Santo António
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Center
city: Jeddah
country: Saudi Arabia
facility: King Fahd Armed Forces Hospital
city: Riyadh
country: Saudi Arabia
facility: King Khalid Univ. Hospital - King Saud University
city: Bloemfontein
country: South Africa
facility: Bloemfontein Medi-Clinic
city: Cape Town
country: South Africa
facility: Christiaan Barnard Memorial Hospital
city: Cape Town
country: South Africa
facility: University of Cape Town - Groote Schuur Hospital
city: Cape Town
country: South Africa
facility: Vincent Pallotti Hospital
city: Johannesburg
country: South Africa
facility: Milpark Hospital
city: Johannesburg
country: South Africa
facility: Sunninghill Hospital
city: Pretoria
country: South Africa
facility: UNITAS Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Bilbao
country: Spain
facility: Hospital de Basurto - Bilbao
city: Burgos
country: Spain
facility: Hospital General Yagüe
city: Caceres
country: Spain
facility: Hospital General San Pedro de Alcantara
city: Ciudad Real
country: Spain
facility: Hospital General de Ciudad Real
city: Donostia-San Sebastian
country: Spain
facility: Hospital de Donostia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Madrid
country: Spain
facility: H. Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Malaga
country: Spain
facility: Hospital Clinico de Malaga - Virgen de la Victoria
city: Palma Mallorca
country: Spain
facility: Hospital Universitario Son Dureta
city: San Juan de Alicante
country: Spain
facility: Hospital Universitario de San Juan
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Ntra. Sra. de la Candelaria
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Vigo
country: Spain
facility: Chuvi-Xeral-Cíes
city: Vitoria / Gasteiz
country: Spain
facility: Hospital de Txagorritxu
Study officials:
affiliation: University of Bonn, Bonn, Germany
name: Jorg O. Schwab, MD
role: STUDY_CHAIR
affiliation: Humanitas Hospital, Milano Italy
name: Maurizio Gasparini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Niguarda Hospital, Milano, Italy
name: Maurizio Lunati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Lüdenscheid, Lüdenscheid, Germany
name: Bernd Lemke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: H. Santa Maria - Lisbon - Portugal
name: João Sousa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town, Cape Town, South Africa
name: Andrzej Okreglicki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Gregorio Marañón, Madrid, Spain
name: Angel Arenal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Antonius hospital - NIEUWEGEIN, The Netherlands
name: Maurits Wijffels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.