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

July 19, 2021 updated by: Abbott Medical Devices

Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sylmar, California, United States, 91342
        • Abbott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

Device: VIP On

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

Device: VIP On

Device: VIP Off

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Arrhythmias
Time Frame: 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.
6 months after randomization
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
Time Frame: 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.
6 months after randomization
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
Time Frame: 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.
6 months after randomization
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
Time Frame: 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.
6 months after randomization
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
Time Frame: 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.
6 months after randomization
Percentage of Patients Experiencing a Study-Related Adverse Event
Time Frame: 6 months after randomization
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
Time Frame: 6 months after randomization
This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.
6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

April 3, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 5, 2006

Study Record Updates

Last Update Posted (Actual)

August 12, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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