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

Not Applicable

Completed

Conditions: Bradycardia

Interventions: Device: Intervention/treatment

Registration Number: NCT00311168

Lead Sponsor: Abbott Medical Devices

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 135

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VIP On, Then VIP Off	Intervention/treatment	Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.
VIP Off, Then VIP On	Intervention/treatment	Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.

Primary Outcome Measures

Name	Time	Method
Percentage of Intrinsic Ventricular Events	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 Outcome Measures

Name	Time	Method
Incidence of Arrhythmias	6 months after randomization	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)	6 months after randomization	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)	6 months after randomization	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)	6 months after randomization	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)	6 months after randomization	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	6 months after randomization	This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.
Number of Auto Mode Switch Events	6 months after randomization	This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.