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Clinical Trials/NCT00366158
NCT00366158
Completed
Not Applicable

EVITA: Evaluation of VIP Feature in Pacemaker Patients

Abbott Medical Devices2 sites in 2 countries461 target enrollmentAugust 2006
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ConditionsArrhythmia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmia
Sponsor
Abbott Medical Devices
Enrollment
461
Locations
2
Primary Endpoint
Percentage of ventricular pacing
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
September 2010
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Percentage of ventricular pacing

Time Frame: 6 and 12 months

Study Sites (2)

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