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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00617175

Recruitment Status : Completed

First Posted : February 15, 2008

Results First Posted : February 25, 2013

Last Update Posted : March 24, 2016

Sponsor:

Information provided by (Responsible Party):

Medtronic Bakken Research Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Heart Disease	Device: Implantable Defibrillator	Phase 4

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:

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

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1902 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Study Start Date :	March 2008
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617175

Show 91 Study Locations

Sponsors and Collaborators

Medtronic Bakken Research Center

Investigators

Layout table for investigator information

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gasparini M, Lunati MG, Proclemer A, Arenal A, Kloppe A, Martínez 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, Martìnez 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. Erratum in: JAMA. 2013 Jun 26;309(24):2552.

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.

Layout table for additonal information

Responsible Party:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00617175 History of Changes
Other Study ID Numbers:	ADVANCE III ADVANCE III
First Posted:	February 15, 2008 Key Record Dates
Results First Posted:	February 25, 2013
Last Update Posted:	March 24, 2016
Last Verified:	March 2016

Keywords provided by Medtronic Bakken Research Center:


Implantable Cardiac Defibrillator therapies reduction Shocks Quality of Life

Additional relevant MeSH terms:

Layout table for MeSH terms

Heart Diseases Cardiovascular Diseases

To Top