Status:
COMPLETED
EVITA: Evaluation of VIP Feature in Pacemaker Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
NA
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 unneces...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT00366158
Start Date
August 1 2006
End Date
September 1 2010
Last Update
February 4 2019
Active Locations (2)
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1
Universitätskliniken Heidelberg
Heidelberg, Germany, 69115
2
Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45