Trial Outcomes & Findings for Reduction of Right Ventricular Pacing Using the Feature Ventricular Intrinsic Preference (VIP) (NCT NCT00311168)
NCT ID: NCT00311168
Last Updated: 2021-08-12
Results Overview
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.
COMPLETED
NA
135 participants
6 months after randomization
2021-08-12
Participant Flow
134 of 135 subjects were randomized. One subject was not randomized.
Participant milestones
| Measure |
VIP On, Then VIP Off
Participants first have the VIP algorithm 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
|
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 Off Device: VIP On
|
|---|---|---|
|
First Intervention
STARTED
|
66
|
68
|
|
First Intervention
COMPLETED
|
59
|
62
|
|
First Intervention
NOT COMPLETED
|
7
|
6
|
|
Second Intervention
STARTED
|
59
|
62
|
|
Second Intervention
COMPLETED
|
49
|
58
|
|
Second Intervention
NOT COMPLETED
|
10
|
4
|
Reasons for withdrawal
| Measure |
VIP On, Then VIP Off
Participants first have the VIP algorithm 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
|
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 Off Device: VIP On
|
|---|---|---|
|
First Intervention
Withdrawal by Subject
|
2
|
2
|
|
First Intervention
Lost to Follow-up
|
1
|
1
|
|
First Intervention
Protocol Violation
|
1
|
1
|
|
First Intervention
Adverse Event
|
1
|
0
|
|
First Intervention
Other
|
2
|
2
|
|
Second Intervention
Lost to Follow-up
|
9
|
2
|
|
Second Intervention
Withdrawal by Subject
|
0
|
1
|
|
Second Intervention
Other
|
1
|
1
|
Baseline Characteristics
67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
Baseline characteristics by cohort
| Measure |
VIP On, Then VIP Off
n=66 Participants
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
|
VIP Off, Then VIP On
n=68 Participants
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
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.3 years
STANDARD_DEVIATION 16.1 • n=66 Participants
|
75.6 years
STANDARD_DEVIATION 10.4 • n=68 Participants
|
74.0 years
STANDARD_DEVIATION 13.6 • n=134 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=64 Participants • 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
|
37 Participants
n=67 Participants • 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
|
67 Participants
n=131 Participants • 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
|
|
Sex: Female, Male
Male
|
34 Participants
n=64 Participants • 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
|
30 Participants
n=67 Participants • 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
|
64 Participants
n=131 Participants • 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF
|
PRIMARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 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.
Outcome measures
| Measure |
VIP On
n=107 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=107 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Percentage of Intrinsic Ventricular Events
|
82.7 % of intrinsic ventricular events
Standard Deviation 28.5
|
22.8 % of intrinsic ventricular events
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 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.
Outcome measures
| Measure |
VIP On
n=102 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=102 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Incidence of Arrhythmias
|
3.6 percentage of burden
Standard Deviation 13
|
2 percentage of burden
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 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.
Outcome measures
| Measure |
VIP On
n=107 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=107 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Percentage of Atrial Sensing to Ventricular Sensing (%PR)
|
41.9 percentage of PR
Standard Deviation 34.2
|
12.3 percentage of PR
Standard Deviation 21
|
SECONDARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 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.
Outcome measures
| Measure |
VIP On
n=108 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=108 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Percentage of Atrial Sensing to Ventricular Pacing (%PV)
|
8.3 percentage of PV
Standard Deviation 18.7
|
37.4 percentage of PV
Standard Deviation 37
|
SECONDARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 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.
Outcome measures
| Measure |
VIP On
n=108 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=108 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Percentage of Atrial Pacing to Ventricular Sensing (%AR)
|
40.5 percentage of AR
Standard Deviation 35
|
10.4 percentage of AR
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 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.
Outcome measures
| Measure |
VIP On
n=107 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=107 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Percentage of Atrial Pacing to Ventricular Pacing (%AV)
|
10.5 percentage of AV
Standard Deviation 21.6
|
38.1 percentage of AV
Standard Deviation 35.2
|
SECONDARY outcome
Timeframe: 6 months after randomizationThis outcome measure evaluated the incidence of study-related adverse events between VIP On and VIP Off.
Outcome measures
| Measure |
VIP On
n=134 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=134 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Percentage of Patients Experiencing a Study-Related Adverse Event
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 months after randomizationPopulation: The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization.
This outcome measure evaluated the difference in the number of auto mode switch events between VIP On and VIP Off.
Outcome measures
| Measure |
VIP On
n=104 Participants
VIP On Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
VIP Off
n=104 Participants
VIP Off Group
* VIP On, then VIP Off
* VIP Off, then VIP On
|
|---|---|---|
|
Number of Auto Mode Switch Events
|
3.1 Counts
Standard Deviation 11.6
|
1.9 Counts
Standard Deviation 5.9
|
Adverse Events
VIP On
VIP Off
Serious adverse events
| Measure |
VIP On
n=134 participants at risk
VIP On Period
|
VIP Off
n=134 participants at risk
VIP Off Period
|
|---|---|---|
|
Product Issues
LEAD DISLODGEMENT OR MIGRATION
|
0.00%
0/134 • 6 months for each intervention
Safety Population included all subjects who were randomized and received at least one of the interventions (VIP On or VIP Off).
|
0.75%
1/134 • Number of events 1 • 6 months for each intervention
Safety Population included all subjects who were randomized and received at least one of the interventions (VIP On or VIP Off).
|
Other adverse events
| Measure |
VIP On
n=134 participants at risk
VIP On Period
|
VIP Off
n=134 participants at risk
VIP Off Period
|
|---|---|---|
|
Product Issues
DIMINISHING R-WAVE AMPLITUDE
|
0.00%
0/134 • 6 months for each intervention
Safety Population included all subjects who were randomized and received at least one of the interventions (VIP On or VIP Off).
|
0.75%
1/134 • Number of events 1 • 6 months for each intervention
Safety Population included all subjects who were randomized and received at least one of the interventions (VIP On or VIP Off).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place