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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010031 S104/ PAS001 |
| Date Original Protocol Accepted |
08/28/2008
|
| Date Current Protocol Accepted |
08/28/2008
|
| Study Name |
Enhanced Surveillance
|
| Device Name |
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO
|
| General Study Protocol Parameters |
| Study Design |
Enhanced Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study is a prospective, non-randomized, combined cohort of subjects followed in two other studies. Data from the combined cohort are used prospectively to assess performance of the algorithm.
|
| Study Population |
Study population same as approved product. This device is a software algorithm designed to identify potential RV-Tip to RV-Ring pace/sense electrode issues earlier than contemporary out-of-range impedance criteria. The RVLIA algorithm uses two different criteria to determine potential lead noise. It uses data from the ventricular sensing integrity counter (SIC) and non-sustained VT episodes (NST) to determine potential noise and also looks at the RV pacing lead impedance values.
|
| Sample Size |
3873 subjects from multiple centers in 2 cohorts
|
| Key Study Endpoints |
Data are collected via review of the databases using the device algorithm. Triggers associated with the algorithm are reviewed. Lead fractures are confirmed.
|
| Follow-up Visits and Length of Follow-up |
The cohort is followed for two years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1779
|
| Actual Number of Sites Enrolled |
n/a
|
| Patient Follow-up Rate |
n/a
|
| Final Safety Findings |
n/a
|
| Final Effect Findings |
Of 41 events, 39 were detected by LIA algorithm, giving an estimated sensitivity of 95.1% (95% IC 83.5%-99.4). The inappropriate shock rate was 21%.
Of 47 LIA triggers, there were eight false-positive alerts increase without lead modification as indicated in the Device Registration System. . The false-positives included two gradually increasing impedance, two T-wave oversensing cases, and one each caused by a header-connector problem, hypothermic ventricular fibrillation during cardiac arrest at cardiac surgery, ventricular fibrillation storm, and one case adjudicated as unknown with abrupt impedance. The estimated number of false positive LIA triggers based on the retrospective analysis was 0.00269 per patient-year.
|
| Study Strengths & Weaknesses |
Not all products were returned for the Return Product Analysis. Of 47 LIA triggers, 21 (47%) of the products were not analyzed, where 15 were not returned and 6 were listed as ¿no record¿.
|
| Recommendations for Labeling Changes |
Labeling changes should be accomplished in accordance with the findings of the PAS.
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