Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III (ADVANCEIII)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||ADVANCE III: Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III|
- 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 ] [ Designated as safety issue: No ]
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.
- 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 ]
|Study Start Date:||March 2008|
|Study Completion Date:||February 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617175
Show 91 Study Locations
|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|