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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P960013 S122/ PAS001 |
| Date Original Protocol Accepted |
05/11/2023
|
| Date Current Protocol Accepted |
|
| Study Name |
UltiPace Lead RWE Study
|
| Device Name |
Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this post-approval study is to evaluate the long-term safety of the Abbott UltiPace lead. The study uses real world evidence data methods to link and evaluate multiple datasets.
|
| Study Population |
All eligible patients who receive an Abbott IPG and UltiPace RA lead or RV lead (model LPA1231) for the first 12 months following UltiPace approval. . Patient inclusion will be further be restricted to those with Medicare Parts A & B coverage and not Part C (HMO) coverage at the time of implant to ensure data capture in Medicare FFS claims.
|
| Sample Size |
Estimated at 7,500 RA leads and 7,500 RV leads. Minimum sample sizes of 645 RA leads and 645 RV leads are needed to provide 80% power to reject the null hypotheses.
|
| Key Study Endpoints |
Primary Endpoints
• Freedom from UltiPace right atrial (RA) lead-related complications through 5 years of follow-up.
• Freedom from UltiPace right ventricular (RV) lead-related complications through 5 years of follow-up.
Secondary Endpoint
• Rate of cardiac tamponade or cardiac perforation events
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
Freedom from RA lead-related complications (n=1,585 leads) was 98.8% (95% CI: 98.3%, 99.2%) at 27 months follow-up.
Freedom from RV lead-related complications (n=935 leads) was 99.0% (95% CI: 98.3%, 99.4%) at 27 months follow-up
There were 13 patients with cardiac tamponade and 0 patients with cardiac perforation events through the data cut-off date. The worst-case scenario rate of RA lead-related cardiac tamponade was 17 events in 11 leads (0.6811% of RA leads). The worst-case scenario rate of RV lead-related cardiac tamponade was <11 events in <11 leads (<1.1555% of RV leads) To comply with the CMS cell size suppression policy, a cell containing a value of 1 to 10 cannot be reported directly. Hence '< 11' is used to report a value of 1 to 10.
Subjects continue to be followed within the study so that the follow-up period will be updated as the study progresses. The minimum sample size for enrollment has been met.
|
| Actual Number of Patients Enrolled |
1,719 subjects were enrolled as of this 36-month report
|
| Actual Number of Sites Enrolled |
202
|
| Patient Follow-up Rate |
N/A
|
