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

Phase 4

Completed

• Conditions: Arrhythmia
• Interventions: Device: Autointrinsic Conduction Search Algorithm

• Registration Number: NCT00187239
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AICS On	Autointrinsic Conduction Search Algorithm	Patients in this arm have Autointrinsic conduction search programmed ON.

Primary Outcome Measures

Name	Time	Method
The primary endpoint is the percentage of intrinsic ventricular events.	3 months

Secondary Outcome Measures

Name	Time	Method
Study related adverse events	3 months
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

Trial Locations

Locations (1)

AtlantiCare Regional Medical Center; 🇺🇸 Pomona, New Jersey, United States