EVITA: Evaluation of VIP Feature in Pacemaker Patients

Overview

The primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2009

Interventions

  • Device: Device: St. Jude Medical Victory dual-chamber pacemaker
    • Pacemaker implant
  • Device: Ventricular Intrinsic Preference
    • Programming of pacemaker

Arms, Groups and Cohorts

  • Experimental: 1
    • Ventricular Instrinsic Preference (VIP) turned ON
  • Active Comparator: 2
    • Ventricular Instrinsic Preference (VIP) turned OFF

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of ventricular pacing
    • Time Frame: 6 and 12 months

Participating in This Clinical Trial

Inclusion Criteria

  • Patient has an indication for implantation of a dual-chamber pacemaker; – Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature. Exclusion Criteria:

  • Patient has persistent or permanent AF/AFl; – Patient has permanent AV Block; – Patient has a pacemaker replacement; – Patient is in NYHA class IV; – Patient is unable to attend the follow-up visits; – Patient is pregnant; – Patient is less than 18 years of age

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Christophe Bailleul, St. Jude Medical
  • Overall Official(s)
    • Alexander Bauer, MD, Study Chair, Universitätskliniken Heidelberg, Heidelberg, 69115, Germany
    • Charles Kennergren, MD, Principal Investigator, Sahlgrenska University Hospital, Sweden

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