Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
The purpose of this study is to determine if patients implanted with a St. Jude Medical (SJM) implantable cardioverter defibrillator (ICD) will benefit by using AutoIntrinsic Conduction Search (AICS) rather than only a programmed AV/PV delay. This study will compare the two methods of programming with respect to intrinsic activity.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)|
- The primary endpoint is the percentage of intrinsic ventricular events. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Frequency of inappropriate ICD therapy during AT/AF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Frequency of appropriate ICD therapy for VT/VF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Study related adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2005|
|Study Completion Date:||August 2007|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
Active Comparator: AICS On
Patients in this arm have Autointrinsic conduction search programmed ON.
Device: Autointrinsic Conduction Search Algorithm
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
No Intervention: AICS Off
Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187239
|United States, New Jersey|
|AtlantiCare Regional Medical Center|
|Pomona, New Jersey, United States|
|Study Director:||Zaffer Syed, MS||St. Jude Medical|