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OpenTrials
Completed

NCT Number: NCT00366158

EVITA: Evaluation of VIP Feature in Pacemaker Patients

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.

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätskliniken Heidelberg, Heidelberg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: St. Jude Medical Victory dual-chamber pacemaker

Device

Pacemaker implant

Ventricular Intrinsic Preference

Device

Programming of pacemaker

Primary outcomes

  1. Percentage of ventricular pacing

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Aug 21, 2006
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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