• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


           

Solia S LBBA EP PASSION


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Study Pending
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) NCT04323670   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.


Solia S LBBA EP PASSION Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 02/28/2025    
1 year report 08/30/2025    
18 month report 02/28/2026    
2 year report 08/30/2026    
30 month report 02/28/2027    
3 year report 08/30/2027    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

-
-