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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014