Back to resultsReduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
Primary Purpose
Bradycardia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention/treatment
Sponsored by
About this trial
This is an interventional diagnostic trial for Bradycardia
Eligibility Criteria
Inclusion Criteria: Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks). At the time of pacemaker implant, VIP™ is programmed "OFF". At the time of enrollment, patient is paced in the RV ≤ 60% of the time. Patient is medically stable. Exclusion Criteria: Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management. Patient is indicated for AF Suppression. Patient has persistent or chronic atrial fibrillation. Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons. Patient is currently participating in another device research study. Patient is younger than 18 years of age. Patient is pregnant. Patients life expectancy is less than 12 months.
Sites / Locations
- Abbott
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
VIP On, Then VIP Off
VIP Off, Then VIP On
Arm Description
Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.
Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.
Outcomes
Primary Outcome Measures
Percentage of Intrinsic Ventricular Events
This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Secondary Outcome Measures
Incidence of Arrhythmias
This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off.
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Percentage of Patients Experiencing a Study-Related Adverse Event
This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.
Number of Auto Mode Switch Events
This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00311168
Brief Title
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
Official Title
Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIP On, Then VIP Off
Arm Type
Experimental
Arm Description
Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.
Arm Title
VIP Off, Then VIP On
Arm Type
Experimental
Arm Description
Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.
Intervention Type
Device
Intervention Name(s)
Intervention/treatment
Intervention Description
Device: VIP On
Device: VIP Off
Primary Outcome Measure Information:
Title
Percentage of Intrinsic Ventricular Events
Description
This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Incidence of Arrhythmias
Description
This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off.
Time Frame
6 months after randomization
Title
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
Description
This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time Frame
6 months after randomization
Title
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
Description
This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time Frame
6 months after randomization
Title
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
Description
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time Frame
6 months after randomization
Title
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
Description
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time Frame
6 months after randomization
Title
Percentage of Patients Experiencing a Study-Related Adverse Event
Description
This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.
Time Frame
6 months after randomization
Title
Number of Auto Mode Switch Events
Description
This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.
Time Frame
6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
At the time of pacemaker implant, VIP™ is programmed "OFF".
At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
Patient is medically stable.
Exclusion Criteria:
Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
Patient is indicated for AF Suppression.
Patient has persistent or chronic atrial fibrillation.
Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
Patient is currently participating in another device research study.
Patient is younger than 18 years of age.
Patient is pregnant.
Patients life expectancy is less than 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clay Cohorn
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Abbott
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
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