Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)

Study Overview
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Brief Summary
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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.

Official Title
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Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

Conditions
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Bradycardia

Intervention / Treatment
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* Device: Intervention/treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIP On, Then VIP Off<br>Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months. | Device: Intervention/treatment<br>* Device: VIP On Device: VIP Off<br>|
| Experimental: VIP Off, Then VIP On<br>Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months. | Device: Intervention/treatment<br>* Device: VIP On Device: VIP Off<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months after randomization | 
| 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. | 6 months after randomization | 
| 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. | 6 months after randomization | 
| 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. | 6 months after randomization | 
| 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. | 6 months after randomization | 
| 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. | 6 months after randomization | 
| 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. | 6 months after randomization |