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

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00311168
First received: April 3, 2006
Last updated: March 28, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Bradycardia
Procedure: VIP On vs VIP Off
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: Reduce Ventricular Pacing Using Ventricular Intrinsic Preference: VIP™ Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percentage of intrinsic ventricular events

Secondary Outcome Measures:
  • Incidence of arrhythmias
  • Percentage of intrinsic and paced events (%PR, %PV, %AR, %AV)
  • Study-related adverse events
  • Percentage of auto mode switch events

Estimated Enrollment: 100
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311168

Locations
United States, California
St. Jude Medical
Sylmar, California, United States, 91342
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Sumati Ramadas, Ph.D. St. Jude Medical
  More Information

No publications provided

Responsible Party: Director, Clinical Affairs, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00311168     History of Changes
Other Study ID Numbers: CRD343
Study First Received: April 3, 2006
Last Updated: March 28, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014