Post-Approval Studies (PAS) Database

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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background