Avoid DeliVering TherApies for Non-Sustained Arrhythmias in ICD PatiEnts III - Full Text View

Sponsored by:	Medtronic Bakken Research Center
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00617175

Purpose

To demonstrate a reduction in the number of therapies (ATP and Shocks) delivered for treating ventricular 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	Intervention	Phase
Heart Disease	Device: Implantable Defibrillator	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Heart Diseases Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ADVANCE III: Avoid DeliVering TherApies for Non-Sustained Arrhythmias in ICD PatiEnts III

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

The primary objective is to demonstrate a 20% reduction of therapies (ATP and Shocks) delivered for treating spontaneous ventricular arrhythmia episodes with a fast cycle length (CL < 320 ms) [ Time Frame: end of study ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1300
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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

Detailed Description:

Primary Objective:

The primary objective is to demonstrate a 20% reduction of therapies (ATP and Shocks) delivered for treating spontaneous ventricular 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617175

Contacts

Contact: Elisabetta Santi, Doctor	003906328141	elisabetta.santi@medtronic.com
Contact: Laura Manotta, MS	003902241371	laura.manotta@medtronic.com

Locations

Germany
University of Bonn	Recruiting
Bonn, Germany
Contact: Elisabetta Santi, MS 003906328141 elisabetta.santi@medtronic.com
Contact: Manotta Laura, MS 003902241371 laura.manotta@medtronic.com
Principal Investigator: Jorg O Schwab, MD

Sponsors and Collaborators

Medtronic Bakken Research Center

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

More Information

Responsible Party:	Medtronic Bakken Research Center ( Elisabetta Santi )
Study ID Numbers:	ADVANCE III, ADVANCE III
Study First Received:	February 4, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00617175
Health Authority:	Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:

Implantable Cardiac Defibrillator
therapies reduction
Shocks
Quality of Life

Study placed in the following topic categories:

Heart Diseases
Shock
Quality of Life
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 10, 2009