EVITA: Evaluation of VIP Feature in Pacemaker Patients

Abbott

Status: Completed

Conditions: Arrhythmia

Treatments: Device: Ventricular Intrinsic Preference; Device: Device: St. Jude Medical Victory dual-chamber pacemaker

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366158

CR06001LV

Details and patient eligibility

About

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.

Enrollment: 461 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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461 participants in 2 patient groups

1

Experimental group

Description:

Ventricular Instrinsic Preference (VIP) turned ON

Treatment:

Device: Device: St. Jude Medical Victory dual-chamber pacemaker

Device: Ventricular Intrinsic Preference

2

Active Comparator group

Description:

Ventricular Instrinsic Preference (VIP) turned OFF

Treatment:

Device: Device: St. Jude Medical Victory dual-chamber pacemaker

Device: Ventricular Intrinsic Preference