Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

Abbott Medical Devices1 site in 1 country135 target enrollmentFebruary 2006

ConditionsBradycardia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Bradycardia
Sponsor: Abbott Medical Devices
Enrollment: 135
Locations: 1
Primary Endpoint: Percentage of Intrinsic Ventricular Events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

September 2008

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Percentage of Intrinsic Ventricular Events

Time Frame: 6 months after randomization

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 Outcomes

Incidence of Arrhythmias(6 months after randomization)
Percentage of Atrial Sensing to Ventricular Sensing (%PR)(6 months after randomization)
Percentage of Atrial Sensing to Ventricular Pacing (%PV)(6 months after randomization)
Percentage of Atrial Pacing to Ventricular Sensing (%AR)(6 months after randomization)
Percentage of Atrial Pacing to Ventricular Pacing (%AV)(6 months after randomization)
Percentage of Patients Experiencing a Study-Related Adverse Event(6 months after randomization)
Number of Auto Mode Switch Events(6 months after randomization)