|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P950022 S085/ PAS001 |
| Date Original Protocol Accepted |
02/21/2014
|
| Date Current Protocol Accepted |
05/20/2020
|
| Study Name |
OptiSure Lead Post Approval Study
|
| Device Name |
OPTISURE
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
Admin Database
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this study is to collect long term safety data of Optisure family of high voltage leads. This study transitions the
Optisure Post Approval Study from a traditional prospective study design to a real world evidence data method for post market
monitoring of the Optisure lead. This method merges multiple real world datasets to assess the Optisure lead performance in a larger
patient population. The proposed method matches patient population datasets from Abbott and Centers for Medicare and
Medicaid Services (CMS) in order to generate data that can be used to evaluate safety of leads in a post market setting.
|
| Study Population |
All patients who had an implant of the Optisure Lead, meet inclusion/exclusion criteria, and link to Medicare FFS claims will be
included in the analysis of this endpoint.
|
| Sample Size |
Assuming the time to first complication follows an exponential distribution and the complication-free survival at 5 years is 95%, a
minimal sample size of 645 patients provides 80% power to reject the null hypothesis of 92.5% complication-free survival years at the 5%
significance level.
It is estimated that 4287 patients with Optisure lead implants will meet inclusion/exclusion criteria and link to Medicare FFS claims for this
study, which greatly exceeds the minimal required sample size.
|
| Key Study Endpoints |
The primary outcome measure is the complication free survival rate at five years for complications related to the Otisure leads.
The secondary outcome measure is a rate of cardiac tamponade or cardiac perforation events.
|
| Follow-up Visits and Length of Follow-up |
The study completion is 5 years after final implant, December 2020. The data retention period will be for 2 years after the submission of the final report.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
4,023 eligible subjects with 4,028 Optisure leads
|
| Actual Number of Sites Enrolled |
N/A
|
| Patient Follow-up Rate |
N/A
|
| Final Safety Findings |
The rate of freedom from Optisure lead related complications was 97.3% for the worst-case scenario
|
| Final Effect Findings |
The rate of all cardiac tamponade and cardiac perforation events during the study time period was 44 events in 28 patients (0.6960% of patients with event) and 7 events in 7 patients (0.1740% of patients with event), respectively
|
| Study Strengths & Weaknesses |
Overall, the results demonstrate the safety of the Optisure family of leads within a large patient population using a real-world data analysis approach. The rate of cardiac tamponade and cardiac perforation events in the Optisure RWE Study remains comparable to what was
observed and reported in the Optisure PAS 72-month clinical study report for Optisure lead related cardiac tamponade and perforation complications. The benefit to risk ratio associated with the Optisure leads remains favorable as determined using RWE analysis. No new risks were identified in the course of the RWE Study.
|
| Recommendations for Labeling Changes |
Yes
|
