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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