Efficacy of the ATP Switch Automatic Programming in Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronization Therapy Defibrillator (CRT-D) Implanted Patients (ASAP)
This study consists in a non-interventional multi-center, prospective study. Primary objective is to assess the efficacy of the new ATP Autoswitch function.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Efficacy of the ATP Switch Automatic Programming in ICD and CRT-D Implanted Patients|
- Ventricular arrhythmia reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
|Paradym VR, DR and CRT models|
The previous range of ICD CRT-systems implements an ATP function, which is designed to reduce the amount of time required to reduce an arrhythmia.
When the device detects the first ventricular tachycardia requiring therapy, it applies the first ATP program and any subsequent programs to reduce the arrhythmia. When the next ventricular tachycardia episode occurs, the device always starts with the same ATP program than the first time.
The new ATP Auto-switch function has been designed in order to increase ATP efficacy towards ventricular arrhythmias (in slow VT and VT zones, i.e. below 200 bpm) reduction as described below, avoiding, if efficient, painful shock therapy:
2 different ATP programs (ATP1 and ATP2) must be programmed in the slow VT and VT zones. When the device detects the first ventricular tachycardia requiring therapy, it applies the first ATP program (ATP1) and the second ATP program (ATP2) if the first attempt was unsuccessful. If ATP1 was applied and was not efficient and ATP2 was applied and was efficient, there is a switch on the next ventricular tachycardia episode: the device starts automatically with ATP2 as a first attempt, followed by ATP1 as a second attempt if necessary
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169246
|Principal Investigator:||SAVOURE Arnaud, MD||CHU Rouen|