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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P950037 S255/ PAS001 |
| Date Original Protocol Accepted |
10/11/2024
|
| Date Current Protocol Accepted |
|
| Study Name |
Solia S LBBA EP PASSION
|
| Device Name |
Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P), Pulse Generator, Permanent, Implantable, Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes
|
| Clinical Trial Number(s) |
NCT05251363
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Real World Evidence (RWE) methodology study with the purpose of evaluating long-term performance of BIOTRONIK’s Solia S lead 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 patients registered in BIOTRONIK’s device tracking database who meet all inclusion criteria and no exclusion criteria with implant date between December 12, 2022, and July 30, 2025, who
1) had a successful Solia S lead implanted in the left bundle branch area, as identified in BIOTRONIK’s device tracking database;
2) are matched with beneficiary file 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 S LBBA lead implant; and,
had 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 S LBBA leads would be required to demonstrate superiority to a complication-free rate of 92.5%.
Number of sites: n/a
Site’s location: n/a
|
| Key Study Endpoints |
Primary endpoint:
Overall incidence of complications attributable to the Solia S LBBA lead through 5 years post-implant.
Secondary endpoints:
1) Incidence of complications attributable to a Solia S LBBA lead or possibly attributable to a Solia S LBBA lead through 5 years post-implant, and
2) Incidence of complications potentially related to a Solia S LBBA lead (e.g. cardiac perforation) not included in another primary or secondary endpoint
|
| Follow-up Visits and Length of Follow-up |
Visits: N/A
Length of F/U: Patients will be followed through at least 5 years following the end of enrollment.
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results
• Primary Endpoint 1 - Overall incidence of complications attributable to the Solia S LBBA lead through 5 years post-implant
(excluding first 30 days). 14 events were reported resulting in an Incidence Rate of 0.014 events/system year. The current lower
confidence interval estimated freedom from complications rate for this endpoint is 95.08%.
• Secondary Endpoint 1 - Incidence of complications attributable to a Solia S LBBA lead or possibly attributable to a Solia S LBBA lead through 5 years post-implant (excluding first 30 days). 23 events were reported resulting in an Incidence Rate of 0.022 events/system year. The current lower confidence interval estimated freedom from complications rate for this endpoint is 93.44%.
• Secondary Endpoint 2 - Incidence of complications potentially related to a Solia S LBBA lead (e.g. cardiac perforation, events occurring within 30 days of implant) not included in another primary or secondary endpoint. Due to CMS cell size suppression policy no information could be provided because the number of qualifying events was <11. The current lower confidence interval estimated freedom from complications rate for this endpoint is 98.42%.
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| Actual Number of Patients Enrolled |
1529
|
| Actual Number of Sites Enrolled |
N/A
|
| Patient Follow-up Rate |
N/A
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