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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P950037 S280/ PAS001 |
| Date Original Protocol Accepted |
04/02/2026
|
| Date Current Protocol Accepted |
04/02/2026
|
| Study Name |
Solia CSP S EP PASSION
|
| Device Name |
Solia CSP S 53; Solia CSP S 60
|
| Clinical Trial Number(s) |
NCT06540079
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective 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 |
Real World Evidence (RWE) methodology study with the purpose of evaluating long-term performance of BIOTRONIK’s Solia CSP S lead when implanted when implanted in the left bundle branch area (LBBA) using active monitoring of Medicare fee-for-service claims data. The study is a retrospective and prospective, single-arm, non-randomized, observational cohort study using RWE methodologies from the Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION) project.
This is a hybrid cohort study in which data are collected both retrospectively and prospectively.
|
| Study Population |
The study will include all U.S. patients registered in BIOTRONIK’s device tracking database who meet all inclusion criteria and no exclusion criteria, who:
1) had a successful Solia CSP S lead implanted, as identified in BIOTRONIK’s device tracking database;
2. are matched with Medicare beneficiary using identifiers obtained from BIOTRONIK’s device tracking database (Social Security Number (including partial), last name, date of birth, gender, and zip code) to a unique beneficiary in the Medicare database;
3) have fee-for-service Medicare coverage during month of successful Solia CSP S lead implant; and,
4) at least 1 Medicare claim in the inpatient, outpatient, or carrier files.
|
| Sample Size |
Number of subjects: At least 750 patients.
Assumptions for sample size estimation: N/A. For primary endpoint 1, a total of 750 evaluable Solia CSP S leads would be required to demonstrate superiority to a complication-free rate of 92.5%.
Number of sites: N/A.
Sites’ locations: N/A.
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| Key Study Endpoints |
Primary Endpoint #1: Overall incidence of complications attributable to the Solia CSP S lead through 5 years post-implant.
Secondary Endpoint #1: Incidence of complications attributable to a Solia CSP S lead or possibly attributable to a Solia CSP S lead through 5 years post-implant.
Secondary Endpoint #2: Incidence of complications potentially related to a Solia CSP S lead (e.g., cardiac perforation) not included in another primary or secondary endpoint.
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| Follow-up Visits and Length of Follow-up |
5 years follow-up
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