EVITA: Evaluation of VIP Feature in Pacemaker Patients
Not Applicable
Completed
- Conditions
- Arrhythmia
- Interventions
- Device: Ventricular Intrinsic Preference
- Registration Number
- NCT00366158
- Lead Sponsor
- Abbott Medical Devices
- 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 unnecessary ventricular pacing in patients with intact AV conduction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 461
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Ventricular Intrinsic Preference Ventricular Instrinsic Preference (VIP) turned OFF 1 Ventricular Intrinsic Preference Ventricular Instrinsic Preference (VIP) turned ON
- Primary Outcome Measures
Name Time Method Percentage of ventricular pacing 6 and 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Universitätskliniken Heidelberg
🇩🇪Heidelberg, Germany