N/A
N=134
Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP)
Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT00311168 ↗Enrolled (actual)
134
Serious AEs
0.4%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Intrinsic Ventricular Events — 82.7; 22.8 % of intrinsic ventricular events — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention/treatment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Intrinsic Ventricular Events |
82.7; 22.8 | <0.0001 sig |
| SECONDARY Incidence of Arrhythmias |
3.6; 2 | — |
| SECONDARY Percentage of Atrial Sensing to Ventricular Sensing (%PR) |
41.9; 12.3 | — |
| SECONDARY Percentage of Atrial Sensing to Ventricular Pacing (%PV) |
8.3; 37.4 | — |
| SECONDARY Percentage of Atrial Pacing to Ventricular Sensing (%AR) |
40.5; 10.4 | — |
| SECONDARY Percentage of Atrial Pacing to Ventricular Pacing (%AV) |
10.5; 38.1 | — |
| SECONDARY Percentage of Patients Experiencing a Study-Related Adverse Event |
0; 2 | — |
| SECONDARY Number of Auto Mode Switch Events |
3.1; 1.9 | — |
Summary
The purpose of this study is to evaluate the efficacy of the VIP™ feature (available in dual chamber Victory® devices) to reduce unnecessary RV pacing, and to determine if patients with implanted SJM pacemakers will benefit by using VIP™ rather than only a programmed AV/PV delay.
Eligibility Criteria
Inclusion Criteria
- Patient has been implanted with dual chamber SJM Victory® device with VIP™ for 1 month (± 2 weeks).
- At the time of pacemaker implant, VIP™ is programmed "OFF".
- At the time of enrollment, patient is paced in the RV ≤ 60% of the time.
- Patient is medically stable.
Exclusion Criteria
- Patient has evidence of complete AV block, such that ventricular pacing would be required as part of the patient's routine management.
- Patient is indicated for AF Suppression.
- Patient has persistent or chronic atrial fibrillation.
- Patient is unable to comply with the follow-up visits due to geographical, psychological, or any other reasons.
- Patient is currently participating in another device research study.
- Patient is younger than 18 years of age.
- Patient is pregnant.
- Patients life expectancy is less than 12 months.
Data sourced from ClinicalTrials.gov (NCT00311168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.