Arrhythmia
Conditions
Keywords
Patients with intact AV conduction
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.
Interventions
DEVICEDevice: St. Jude Medical Victory dual-chamber pacemaker
Pacemaker implant
DEVICEVentricular Intrinsic Preference
Programming of pacemaker
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ventricular pacing | 6 and 12 months |
Countries
Germany, Sweden
Outcome results
None listed