Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study

Study Overview
=================
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.

Official Title
-----------------
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: Autointrinsic Conduction Search Algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AICS On<br>Patients in this arm have Autointrinsic conduction search programmed ON. | Device: Autointrinsic Conduction Search Algorithm<br>* Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.<br>|
| No Intervention: AICS Off<br>Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint is the percentage of intrinsic ventricular events. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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.