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
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: 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 August 20, 2014