Arrhythmia
Conditions
Keywords
ICDs, Ventricular pacing, Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks)., At the time of enrollment, patient is paced in the RV ≤25% of the time as determined by the device diagnostics., Patient is medically stable.
Brief summary
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.
Interventions
DEVICEAutointrinsic Conduction Search Algorithm
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has been implanted with a dual chamber SJM ICD with AICS for 1 month (± 2 weeks). * At the time of enrollment, patient is paced in the right ventricle (RV) ≤25% of the time as determined by the device diagnostics. * Patient is medically stable.
Exclusion criteria
* Patient has evidence of atrioventricular (AV) block (first, second or third degree) such that ventricular pacing would be required as part of the patient's routine management * Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons. * Patient is younger than 18 years of age. * Patient is pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the percentage of intrinsic ventricular events. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes | 3 months |
| Frequency of inappropriate ICD therapy during AT/AF | 3 months |
| Frequency of appropriate ICD therapy for VT/VF | 3 months |
| Study related adverse events | 3 months |
Countries
United States
Outcome results
None listed