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

This study is ongoing, but not recruiting participants.

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00187239

Purpose

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.

Condition	Intervention	Phase
Arrhythmia	Device: Autointrinsic Conduction Search Algorithm	Phase IV

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

The primary endpoint is the percentage of intrinsic ventricular events.

Secondary Outcome Measures:

Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes
Frequency of inappropriate ICD therapy during AT/AF
Frequency of appropriate ICD therapy for VT/VF
Study related adverse events

Estimated Enrollment:	140
Study Start Date:	July 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187239

Locations

United States, New Jersey
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:

Zaffer Syed, MS

St. Jude Medical

More Information

Study ID Numbers:	CRD292
Study First Received:	September 10, 2005
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00187239
Health Authority:	United States: Institutional Review Board

Keywords provided by St. Jude Medical:

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.

Study placed in the following topic categories:

Heart Diseases
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009