EVITA: Evaluation of VIP Feature in Pacemaker Patients

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00366158
First received: August 18, 2006
Last updated: October 8, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Arrhythmia
Device: Device: St. Jude Medical Victory dual-chamber pacemaker
Device: Ventricular Intrinsic Preference

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: EVITA: Evaluation of VIP Feature in Pacemaker Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percentage of ventricular pacing [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 461
Study Start Date: August 2006
Study Completion Date: September 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ventricular Instrinsic Preference (VIP) turned ON
Device: Device: St. Jude Medical Victory dual-chamber pacemaker
Pacemaker implant
Device: Ventricular Intrinsic Preference
Programming of pacemaker
Active Comparator: 2
Ventricular Instrinsic Preference (VIP) turned OFF
Device: Device: St. Jude Medical Victory dual-chamber pacemaker
Pacemaker implant
Device: Ventricular Intrinsic Preference
Programming of pacemaker

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366158

Locations
Germany
Universitätskliniken Heidelberg
Heidelberg, Germany, 69115
Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Alexander Bauer, MD Universitätskliniken Heidelberg, Heidelberg, 69115, Germany
Principal Investigator: Charles Kennergren, MD Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Christophe Bailleul, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00366158     History of Changes
Other Study ID Numbers: CR06001LV
Study First Received: August 18, 2006
Last Updated: October 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by St. Jude Medical:
Patients with intact AV conduction

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

ClinicalTrials.gov processed this record on April 14, 2014