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

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187239
• Other study ID #: CRD292
• Status: Completed
• Phase: Phase 4
• Start date: July 2005
• Est. completion date: August 2007

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Device:
• Autointrinsic Conduction Search Algorithm
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.

Locations

Country	Name	City	State
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the percentage of intrinsic ventricular events.		3 months
Secondary	Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes		3 months
Secondary	Frequency of inappropriate ICD therapy during AT/AF		3 months
Secondary	Frequency of appropriate ICD therapy for VT/VF		3 months
Secondary	Study related adverse events		3 months