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

NCT00617175 | Completed Phase 4 Results DMC

• 1 other identifier: ADVANCE III
• Study Type: interventional
• Target: 1,902
• Locations: 14 countries
• Sites: 91

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.

Conditions

Heart Disease

Keywords

Implantable Cardiac Defibrillator; therapies reduction; Shocks; Quality of Life

Outcome Measures

Primary Outcomes (1)

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

  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 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.

  end of study

Study Arms (2)

Long NID

EXPERIMENTAL

Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia

Device: Implantable Defibrillator

Short NID

ACTIVE COMPARATOR

Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia

Device: Implantable Defibrillator

Interventions

Implantable Defibrillator DEVICE

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

Long NID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (91)

Hopital St-Joseph

Gilly, Belgium

Location

CHU Brugmann

Laken, Belgium

Location

CHR La Citadelle Liege

Liège, Belgium

Location

CHR Namur

Namur, Belgium

Location

AZ Nikolaas

Sint-Niklaas, Belgium

Location

KAS Gentofte

Hellerup, Denmark

Location

Odense Universitets Hospital

Odense, Denmark

Location

Turku University Central Hospital

Turku, Finland

Location

Hôpital Michalon- CHU Grenoble

Grenoble, France

Location

CHU Nantes - Hôpital Guillaume et René Laënnec

Nantes, France

Location

NCN Nantes

Nantes, France

Location

Hopital de la Pitie Salpetriere

Paris, France

Location

Centre Hospitalier de Pau

Pau, France

Location

CHU Hôpital de Pontchaillou Rennes

Rennes, France

Location

CH Rangueil Toulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

RWTH Aachen

Aachen, Germany

Location

University of Bonn

Bonn, Germany

Location

Kardiologisches Zentrum an der Klinik Rotes Kreuz

Frankfurt am Main, Germany

Location

SRH Wald-Klinikum Gera gGmbH

Gera, Germany

Location

Universitätskliniken des Saarlandes

Homburg, Germany

Location

Klinikum Lüdenscheid

Lüdenscheid, Germany

Location

Klinikum Dorothea Christiane Erxleben Quedlinburg

Quedlinburg, Germany

Location

Universität Rostock- Medizinische Fakultät

Rostock, Germany

Location

Diakoniekrankenhaus Rotenburg

Rotenburg (Wümme), Germany

Location

Semmelweis University AOK

Budapest, Hungary

Location

Zala County Hospital

Zalaegerszeg, Hungary

Location

Presidio Ospedaliero di Venere

Carbonara, Bari, Italy

Location

Azienda.Ospedaliera.G.M. Lancisi

Ancona, Italy

Location

Azienda Ospedaliera G. Rummo

Benevento, Italy

Location

Cliniche Gavazzeni

Bergamo, Italy

Location

Stab. Ospedaliero Di Summa-Perrino - Brindisi

Brindisi, Italy

Location

Casa di Cura Mater Domini

Castellanza, Italy

Location

Ospedale Pugliese e Ciaccio

Catanzaro, Italy

Location

A.O. Santa Croce e Carle

Cuneo, Italy

Location

Ente Ospedaliero Ospedali Galliera - Genova

Genova, Italy

Location

Ospedale Maggiore di Lodi

Lodi, Italy

Location

Istituto Ca' Granda-Niguarda

Milan, Italy

Location

San Carlo Borromeo

Milan, Italy

Location

Nuovo Osp. Civile S. Agostino

Modena, Italy

Location

P.O. di Montebelluna

Montebelluna, Italy

Location

Ospedale S. Giacomo

Novi Ligure, Italy

Location

Policlinico S. Matteo

Pavia, Italy

Location

Osp. S. Maria degli Angeli - Pordenone

Pordenone, Italy

Location

Ospedale Misericordia e Dolce

Prato, Italy

Location

Azienda Complesso Ospedaliero San Filippo Neri

Roma, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

Ospedale Sant Eugenio

Roma, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Osp. S. Giovanni di Dio e Ruggi dAragona

Salerno, Italy

Location

AZ. Osp. Ordine Mauriziano

Torino, Italy

Location

A.O. S.Maria della Misericordia

Udine, Italy

Location

ULSS N.6 S. Bortolo - Vicenza

Vicenza, Italy

Location

Medisch Spectrum Twente

Enschede, Netherlands

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

Location

Zoz Mswia

Bialystok, Poland

Location

Hospital Garcia Orta, SA

Almada, Portugal

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

Hospital de Santa Marta

Lisbon, Portugal

Location

Hospital Geral de Santo António

Porto, Portugal

Location

Tyumen Cardiology Center

Tyumen, Russia

Location

King Fahd Armed Forces Hospital

Jeddah, Saudi Arabia

Location

King Khalid Univ. Hospital - King Saud University

Riyadh, Saudi Arabia

Location

Bloemfontein Medi-Clinic

Bloemfontein, South Africa

Location

Christiaan Barnard Memorial Hospital

Cape Town, South Africa

Location

University of Cape Town - Groote Schuur Hospital

Cape Town, South Africa

Location

Vincent Pallotti Hospital

Cape Town, South Africa

Location

Milpark Hospital

Johannesburg, South Africa

Location

Sunninghill Hospital

Johannesburg, South Africa

Location

UNITAS Hospital

Pretoria, South Africa

Location

Hospital General Universitario de Alicante

Alicante, Spain

Location

Hospital de Basurto - Bilbao

Bilbao, Spain

Location

Hospital General Yagüe

Burgos, Spain

Location

Hospital General San Pedro de Alcantara

Cáceres, Spain

Location

Hospital General de Ciudad Real

Ciudad Real, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

H. Ramón y Cajal

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Location

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Clinico de Malaga - Virgen de la Victoria

Málaga, Spain

Location

Hospital Universitario Son Dureta

Palma Mallorca, Spain

Location

Hospital Universitario de San Juan

Sant Joan d'Alacant, Spain

Location

Hospital Ntra. Sra. de la Candelaria

Santa Cruz de Tenerife, Spain

Location

Hospital Universitario de Canarias

Santa Cruz de Tenerife, Spain

Location

Hospital Virgen de La Salud

Toledo, Spain

Location

Hospital Arnau de Vilanova

Valencia, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, Spain

Location

Chuvi-Xeral-Cíes

Vigo, Spain

Location

Hospital de Txagorritxu

Vitoria-Gasteiz, Spain

Location

Related Publications (7)

• 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.

  PMID: 34392257 DERIVED

• 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.

  PMID: 31826936 DERIVED

• 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.

  PMID: 29759624 DERIVED

• 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.

  PMID: 29251799 DERIVED

• 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.

  PMID: 24838360 DERIVED

• 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.

  PMID: 23652522 DERIVED

• 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.

  PMID: 19175450 DERIVED

MeSH Terms

Conditions

Heart Diseases; Shock

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Results Point of Contact

• Title: Laura Manotta
• Organization: MEDTRONIC Clinical Research Institute

laura.manotta@medtronic.com

+39022413.1

Study Officials

• Jorg O. Schwab, MD

  University of Bonn, Bonn, Germany

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: July 2, 2025
• Results First Posted: February 25, 2013

Record last verified: 2025-06

Locations

ES (21); FR (8); NL (2); PT (4); RU (1); ZA (7); BE (5); SA (2); DK (2); FI (1); IT (26); HU (2); PL (1); DE (9)