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

Abbott Medical Devices135 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

135

Conditions

Bradycardia

Interventions

Intervention/treatmentDEVICE

Device: VIP On Device: VIP Off

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Abbott

Sylmar, California, United States

Outcomes

Primary Outcomes

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.