Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Arrhythmia Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

The primary endpoint is the percentage of intrinsic ventricular events. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Frequency of inappropriate ICD therapy during AT/AF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Frequency of appropriate ICD therapy for VT/VF [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Study related adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment:	157
Study Start Date:	July 2005
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: AICS On Patients in this arm have Autointrinsic conduction search programmed ON.	Device: Autointrinsic Conduction Search Algorithm Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
No Intervention: AICS Off Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.	Device: Autointrinsic Conduction Search Algorithm Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

No publications provided

Responsible Party:	Director, Scientific Studies, St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00187239 History of Changes
Other Study ID Numbers:	CRD292
Study First Received:	September 10, 2005
Last Updated:	July 12, 2011
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.

Additional relevant MeSH terms:

Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012