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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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.

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WiSE CRT System Post-Approval Study (PAS)


General
Study Status Study Pending
Application Number /
Requirement Number		 P240028 / PAS001
Date Original Protocol Accepted 06/18/2025
Date Current Protocol Accepted 06/18/2025
Study Name WiSE CRT System Post-Approval Study (PAS)
Device Name WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
Clinical Trial Number(s) NCT02922036 
General Study Protocol Parameters
Study Design Other Study Design
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The WiSE-UP Registry is a prospective, non-randomized, observational, multi-center study tracking patients implanted with the WiSE System to understand clinical outcomes, CRT response, & long-term product performance. Patients enrolled in the study will be followed per the standard of care practices of their provider.
Study Population Adults at least 22 years of age
Sample Size Number of subjects: 320
Assumptions for sample size estimation:
• Projected attrition rates of 10% annual mortality and 15% annual loss to follow-up.
• Estimate a 1-month 15% event rate based on the observed rate during the SOLVE-CRT Pivotal Study
• Estimation that at least 275 patients will complete 1-month follow-up.
• Estimation that approximately 240 patients will remain evaluable at 1 year.
Number of sites: 50
Sites location: US and OUS
Key Study Endpoints The rate of serious adverse events (SAEs) at < 30 days post implant related to the WiSE System and/or implant procedure.
Secondary Endpoints: The outcome measures for this study include the following evaluations:
• Procedural Success
• CRT Response Assessment
• HF Clinical Composite Score
• NYHA Classification
• QRS Duration
• Minnesota Living with Heart Failure Questionnaire (6 & 12 months only)
• Events Assessment
• Mortality
• Patient Global Assessment
• Device Longevity & Battery Performance
• Left Ventricular End-Systolic Volume (LVESV)
Follow-up Visits and Length of Follow-up Baseline visit, 1 month, 6 months, annually for 5 years


WiSE CRT System Post-Approval Study (PAS) Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/18/2025    
1 year report 06/18/2026    
18 month report 12/18/2026    
2 year report 06/18/2027    
3 year report 06/18/2028    
4 year report 06/18/2029    


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

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