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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIP On, Then VIP Off | Experimental | Participants first have VIP programmed On after randomization until 3 months, followed by VIP programmed Off from 3 to 6 months. |
|
| VIP Off, Then VIP On | Experimental | Participants first have VIP programmed Off after randomization until 3 months, followed by VIP programmed On from 3 to 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention/treatment | Device | Device: VIP On Device: VIP Off |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after randomization |
| Percentage of Atrial Sensing to Ventricular Sensing (%PR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clay Cohorn | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott | Sylmar | California | 91342 | United States |
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134 of 135 subjects were randomized. One subject was not randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Second Intervention |
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A total of 135 subjects were enrolled in the study and 134 of these 135 subjects were randomized. The 134 randomized subjects are included in the baseline analysis population.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | VIP Off, Then VIP On |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | % of intrinsic ventricular events | 6 months after randomization |
|
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VIP On | VIP On Period | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEAD DISLODGEMENT OR MIGRATION | Product Issues | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DIMINISHING R-WAVE AMPLITUDE | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clay Cohorn - Director, Clinical Research | Abbott | 469-929-7116 | clay.cohorn@abbott.com |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D008722 | Methods |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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. |
| 6 months after randomization |
| 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. | 6 months after randomization |
| 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. | 6 months after randomization |
| 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. | 6 months after randomization |
| 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. | 6 months after randomization |
| 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. | 6 months after randomization |
| Protocol Violation |
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| Adverse Event |
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| Other |
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| NOT COMPLETED |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | 67/68 subjects (VIP On, then VIP Off) and 64/66 subjects (VIP Off, then VIP On) have gender information collected on the CRF | Count of Participants | Participants |
|
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| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | percentage of burden | 6 months after randomization |
|
|
|
| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | percentage of PR | 6 months after randomization |
|
|
|
| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | percentage of PV | 6 months after randomization |
|
|
|
| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | percentage of AR | 6 months after randomization |
|
|
|
| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | percentage of AV | 6 months after randomization |
|
|
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| 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. | Posted | Count of Participants | Participants | 6 months after randomization |
|
|
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| 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. | The analysis population includes patients enrolled in the study with data available on the outcome measure at 6 months after randomization. | Posted | Mean | Standard Deviation | Counts | 6 months after randomization |
|
|
|
| 134 |
| 0 |
| 134 |
| 0 |
| 134 |
| EG001 | VIP Off | VIP Off Period | 0 | 134 | 1 | 134 | 1 | 134 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |