EVITA: Evaluation of VIP Feature in Pacemaker Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 461
- Locations
- 2
- Primary Endpoint
- Percentage of ventricular pacing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
2
Ventricular Instrinsic Preference (VIP) turned OFF
Intervention: Device: St. Jude Medical Victory dual-chamber pacemaker (Device)
2
Ventricular Instrinsic Preference (VIP) turned OFF
Intervention: Ventricular Intrinsic Preference (Device)
1
Ventricular Instrinsic Preference (VIP) turned ON
Intervention: Device: St. Jude Medical Victory dual-chamber pacemaker (Device)
1
Ventricular Instrinsic Preference (VIP) turned ON
Intervention: Ventricular Intrinsic Preference (Device)
Outcomes
Primary Outcomes
Percentage of ventricular pacing
Time Frame: 6 and 12 months
Secondary Outcomes
No secondary outcomes reported