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

Abbott Medical Devices1 site in 1 country157 target enrollmentStarted: July 2005Last updated: February 4, 2019

Conditions

Trial Snapshot

Phase: Phase 4
Status: Completed
Sponsor: Abbott Medical Devices
Enrollment: 157
Locations: 1
Primary Endpoint: The primary endpoint is the percentage of intrinsic ventricular events.

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts 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.

Outcomes

Primary Outcomes

The primary endpoint is the percentage of intrinsic ventricular events.

Time Frame: 3 months

Secondary Outcomes

Frequency of appropriate ICD therapy for VT/VF(3 months)
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)

Investigators

Sponsor

Abbott Medical Devices

Sponsor Class

Industry

Study Sites (1)

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