Bradycardia
Conditions
Brief 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.
Interventions
DEVICEIntervention/treatment
Device: VIP On Device: VIP Off
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Intrinsic Ventricular Events | 6 months after randomization | This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Atrial Sensing to Ventricular Sensing (%PR) | 6 months after randomization | This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing. |
| Percentage of Atrial Sensing to Ventricular Pacing (%PV) | 6 months after randomization | This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing. |
| Percentage of Atrial Pacing to Ventricular Sensing (%AR) | 6 months after randomization | This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing. |
| Incidence of Arrhythmias | 6 months after randomization | This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off. |
| Percentage of Patients Experiencing a Study-Related Adverse Event | 6 months after randomization | This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off. |
| Number of Auto Mode Switch Events | 6 months after randomization | This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off. |
| Percentage of Atrial Pacing to Ventricular Pacing (%AV) | 6 months after randomization | This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing. |
Countries
United States
Participant flow
Pre-assignment details
134 of 135 subjects were randomized. One subject was not randomized.
Participants by arm
| Arm | Count |
|---|---|
| VIP On, Then VIP Off Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months.
Intervention/treatment:
Device: VIP On Device: VIP Off | 66 |
| VIP Off, Then VIP On Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months.
Intervention/treatment:
Device: VIP On Device: VIP Off | 68 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 1 | 0 |
| First Intervention | Lost to Follow-up | 1 | 1 |
| First Intervention | Other | 2 | 2 |
| First Intervention | Protocol Violation | 1 | 1 |
| First Intervention | Withdrawal by Subject | 2 | 2 |
| Second Intervention | Lost to Follow-up | 9 | 2 |
| Second Intervention | Other | 1 | 1 |
| Second Intervention | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | VIP On, Then VIP Off | VIP Off, Then VIP On | Total |
|---|---|---|---|
| Age, Continuous | 72.3 years STANDARD_DEVIATION 16.1 | 75.6 years STANDARD_DEVIATION 10.4 | 74.0 years STANDARD_DEVIATION 13.6 |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 67 Participants |
| Sex: Female, Male Male | 34 Participants | 30 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 134 | 0 / 134 |
| other Total, other adverse events | 0 / 134 | 1 / 134 |
| serious Total, serious adverse events | 0 / 134 | 1 / 134 |
Outcome results
Primary
Percentage of Intrinsic Ventricular Events
This outcome measured evaluated the difference in the percentage of intrinsic ventricular events between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Percentage of Intrinsic Ventricular Events | 82.7 % of intrinsic ventricular events | Standard Deviation 28.5 |
| VIP Off | Percentage of Intrinsic Ventricular Events | 22.8 % of intrinsic ventricular events | Standard Deviation 31.3 |
p-value: <0.000195% CI: [-67.5, -52.9]t-test, 2 sided
Secondary
Incidence of Arrhythmias
This outcome measure evaluated the difference in the percentage of time a patient spent in atrial tachycardia/atrial fibrillation (arrhythmia burden) calculated by the device between VIP On and VIP Off.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Incidence of Arrhythmias | 3.6 percentage of burden | Standard Deviation 13 |
| VIP Off | Incidence of Arrhythmias | 2 percentage of burden | Standard Deviation 6.3 |
Secondary
Number of Auto Mode Switch Events
This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Number of Auto Mode Switch Events | 3.1 Counts | Standard Deviation 11.6 |
| VIP Off | Number of Auto Mode Switch Events | 1.9 Counts | Standard Deviation 5.9 |
Secondary
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Pacing (%AV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Percentage of Atrial Pacing to Ventricular Pacing (%AV) | 10.5 percentage of AV | Standard Deviation 21.6 |
| VIP Off | Percentage of Atrial Pacing to Ventricular Pacing (%AV) | 38.1 percentage of AV | Standard Deviation 35.2 |
Secondary
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
This outcome measure evaluated the difference in the percentage of Atrial Pacing to Ventricular Sensing (%AR) between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Percentage of Atrial Pacing to Ventricular Sensing (%AR) | 40.5 percentage of AR | Standard Deviation 35 |
| VIP Off | Percentage of Atrial Pacing to Ventricular Sensing (%AR) | 10.4 percentage of AR | Standard Deviation 20.3 |
Secondary
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
This outcome measure evaluated the difference in the percentage of Atrial Sensing to Ventricular Pacing (%PV) between VIP On and VIP Off. A lower percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Percentage of Atrial Sensing to Ventricular Pacing (%PV) | 8.3 percentage of PV | Standard Deviation 18.7 |
| VIP Off | Percentage of Atrial Sensing to Ventricular Pacing (%PV) | 37.4 percentage of PV | Standard Deviation 37 |
Secondary
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
This outcome measure evaluated the difference in the percentage of atrial sensing to ventricular sensing (%PR) detected by the device between VIP On and VIP Off. A higher percentage indicates more intrinsic ventricular events and a lower amount of unnecessary RV pacing.
Time frame: 6 months after randomization
Population: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIP On | Percentage of Atrial Sensing to Ventricular Sensing (%PR) | 41.9 percentage of PR | Standard Deviation 34.2 |
| VIP Off | Percentage of Atrial Sensing to Ventricular Sensing (%PR) | 12.3 percentage of PR | Standard Deviation 21 |
Secondary
Percentage of Patients Experiencing a Study-Related Adverse Event
This outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.
Time frame: 6 months after randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VIP On | Percentage of Patients Experiencing a Study-Related Adverse Event | 0 Participants |
| VIP Off | Percentage of Patients Experiencing a Study-Related Adverse Event | 2 Participants |