NCT00366158

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
461

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

August 18, 2006

Last Update Submit

February 1, 2019

Conditions

Arrhythmia

Keywords

Patients with intact AV conduction

Outcome Measures

Primary Outcomes (1)

  • Percentage of ventricular pacing

    6 and 12 months

Study Arms (2)

1

EXPERIMENTAL

Ventricular Instrinsic Preference (VIP) turned ON

Device: Device: St. Jude Medical Victory dual-chamber pacemakerDevice: Ventricular Intrinsic Preference

2

ACTIVE COMPARATOR

Ventricular Instrinsic Preference (VIP) turned OFF

Device: Device: St. Jude Medical Victory dual-chamber pacemakerDevice: Ventricular Intrinsic Preference

Interventions

Device: St. Jude Medical Victory dual-chamber pacemakerDEVICE

Pacemaker implant

12
Ventricular Intrinsic PreferenceDEVICE

Programming of pacemaker

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätskliniken Heidelberg

Heidelberg, 69115, Germany

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

  • Bauer A, Vermeulen J, Toivonen L, Voitk J, Barr C, Peytchev P. Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial. Herzschrittmacherther Elektrophysiol. 2015 Dec;26(4):359-66. doi: 10.1007/s00399-015-0394-2. Epub 2015 Aug 28.

    PMID: 26315154DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Bauer, MD

    Universitätskliniken Heidelberg, Heidelberg, 69115, Germany

    STUDY CHAIR

  • Charles Kennergren, MD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 21, 2006

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

September 1, 2010

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

SE(1)DE(1)