EVITA: Evaluation of VIP Feature in Pacemaker Patients

Arrhythmia Clinical Trial

Official title:

EVITA: Evaluation of VIP Feature in Pacemaker Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366158
• Other study ID #: CR06001LV
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: September 2010

Study information

• Verified date: February 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 461
• Est. completion date: September 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Device:
• Device: St. Jude Medical Victory dual-chamber pacemaker
Pacemaker implant
• Ventricular Intrinsic Preference
Programming of pacemaker

Locations

Country	Name	City	State
Germany	Universitätskliniken Heidelberg	Heidelberg
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of ventricular pacing		6 and 12 months