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

Bradycardia Clinical Trial

Official title:

Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311168
• Other study ID #: CRD343
• Status: Completed
• Phase: N/A
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: July 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bradycardia

Intervention

Device:
• Intervention/treatment
Device: VIP On Device: VIP Off

Locations

Country	Name	City	State
United States	Abbott	Sylmar	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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