EVITA: Evaluation of VIP Feature in Pacemaker Patients

February 1, 2019 updated by: Abbott Medical Devices
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69115
        • Universitätskliniken Heidelberg
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of ventricular pacing
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: Alexander Bauer, MD, Universitätskliniken Heidelberg, Heidelberg, 69115, Germany
  • Principal Investigator: Charles Kennergren, MD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 18, 2006

First Submitted That Met QC Criteria

August 18, 2006

First Posted (Estimate)

August 21, 2006

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR06001LV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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