Back to resultsReduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
Primary Purpose
Arrhythmia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Autointrinsic Conduction Search Algorithm
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmia focused on measuring 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.
Eligibility 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.
Sites / Locations
- AtlantiCare Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
AICS On
AICS Off
Arm Description
Patients in this arm have Autointrinsic conduction search programmed ON.
Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.
Outcomes
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
Full Information
NCT ID
NCT00187239
First Posted
September 10, 2005
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00187239
Brief Title
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
Official Title
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search (REDUCE Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott Medical Devices
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia
Keywords
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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AICS On
Arm Type
Active Comparator
Arm Description
Patients in this arm have Autointrinsic conduction search programmed ON.
Arm Title
AICS Off
Arm Type
No Intervention
Arm Description
Patients assigned to this arm do not have Autointrinsic Conduction Search programmed on.
Intervention Type
Device
Intervention Name(s)
Autointrinsic Conduction Search Algorithm
Intervention Description
Autointrinsic conduction search is programmed on in those patients randomized to AICS ON.
Primary Outcome Measure Information:
Title
The primary endpoint is the percentage of intrinsic ventricular events.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of atrial tachycardia (AT), atrial fibrillation (AF), ventricular tachycardia (VT), and ventricular fibrillation (VF) episodes
Time Frame
3 months
Title
Frequency of inappropriate ICD therapy during AT/AF
Time Frame
3 months
Title
Frequency of appropriate ICD therapy for VT/VF
Time Frame
3 months
Title
Study related adverse events
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaffer Syed, MS
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
AtlantiCare Regional Medical Center
City
Pomona
State/Province
New Jersey
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Reduce Ventricular Pacing in Dual Chamber Implantable Cardioverter Defibrillators Using AutoIntrinsic Conduction Search Study
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