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Sponsored by: |
Medtronic Bakken Research Center |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00617175 |
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 |
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Heart Disease |
Device: Implantable Defibrillator |
Phase IV |
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 |
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 |
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1: Experimental
Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
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Device: Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
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2: Active Comparator
Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
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Device: Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia
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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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Elisabetta Santi, Doctor | 003906328141 | elisabetta.santi@medtronic.com |
Contact: Laura Manotta, MS | 003902241371 | laura.manotta@medtronic.com |
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 |
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 |
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 History of Changes |
Health Authority: | Italy: Ministry of Health |
Implantable Cardiac Defibrillator therapies reduction Shocks Quality of Life |
Heart Diseases Shock Quality of Life Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac |