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OpenTrials
Completed

NCT Number: NCT00311168

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

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abbott

Sylmar, California, 91342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention/treatment

Device

Device: VIP On

Device: VIP Off

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Apr 5, 2006
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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