|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P950022 S085/ PAS002 |
Date Original Protocol Accepted |
02/21/2014
|
Date Current Protocol Accepted |
02/21/2014
|
Study Name |
Externalization and Abrasion Sub-Study
|
Device Name |
OPTISURE
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
477 subjects from the main study were consented and enrolled in the sub study
|
Actual Number of Sites Enrolled |
60 clinical sites
|
Patient Follow-up Rate |
As of the cut-off date for this report, in the sub-study a total of 370 subjects have completed the 12 month visit, 335 subjects have completed the 24 month, 279 subjects have completed the 36 month, 233 have completed the 48 month follow-up visit, and 9 have completed the 60 month visit, which includes some of the initial cinefluoroscopy evaluations for the sub-study.
|
Final Safety Findings |
There were a total of 5 adverse events (3 complications and 2 observations) reported post Optisure lead interventions. The complications were related to the following: Lead Dislodgement or Migration and Pericardial Effusion. The observations were related to the following: Bleeding and other.
|
Final Effect Findings |
There are 10 cases of Optisure RV leads that were adjudicated by the Electrical Data Adjudication Committee (EDAC). Of the 10 cases, 1 was adjudicated as having electrical dysfunction. The others had reasons other than the integrity of the lead as the cause for electrical abnormalities. The sponsor states that as of the cutoff date of this report, zero externalized conductors, zero visual lead anomalies and zero other insulation anomalies have been identified by the CAC for the Optisure RV leads.
|
Study Strengths & Weaknesses |
There has been no incidence of externalized conductors (EC) or visual lead anomalies (VLA) in Optisure leads as measured throughout >4 years of follow-up in the sub-study.
|
Recommendations for Labeling Changes |
No
|