EVITA: Evaluation of VIP Feature in Pacemaker Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Arrhythmia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Ventricular Instrinsic Preference (VIP) turned ON

Group Type EXPERIMENTAL

Device: St. Jude Medical Victory dual-chamber pacemaker

Intervention Type DEVICE

Pacemaker implant

Ventricular Intrinsic Preference

Intervention Type DEVICE

Programming of pacemaker

2

Ventricular Instrinsic Preference (VIP) turned OFF

Group Type ACTIVE_COMPARATOR

Device: St. Jude Medical Victory dual-chamber pacemaker

Intervention Type DEVICE

Pacemaker implant

Ventricular Intrinsic Preference

Intervention Type DEVICE

Programming of pacemaker

Interventions

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Device: St. Jude Medical Victory dual-chamber pacemaker

Pacemaker implant

Intervention Type DEVICE

Ventricular Intrinsic Preference

Programming of pacemaker

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No