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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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PROACTIVE-HF Study


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General
Study Status Ongoing
Application Number /
Requirement Number
P230040 / PAS001
Date Original Protocol Accepted 10/04/2024
Date Current Protocol Accepted 01/17/2025
Study Name PROACTIVE-HF Study
Device Name Cordella Pulmonary Artery Sensor System (CorPASS)
Clinical Trial Number(s) NCT04089059 
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives A randomized control trials will be conducted in NYHA Class III.
This is a prospective, open label, randomized, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients enrolled with NYHA Class III Heart Failure.
Study Population Adults diagnosed with NYHA Class III Heart Failure at enrollment
Sample Size NYHA Class III
Phase I aims to explore the trend at 6 months between the treatment and control arms. With 600 patients and 6 months of follow-up, and assuming a 5% dropout rate per year, this phase will descriptively examine trends in cumulative count curve separation between the two arms without conducting formal hypothesis testing. No formal Type I error rate will be assigned.
Assumptions for sample size estimation: 600 patients
Number of sites: 120
Sites location: US and Europe
Key Study Endpoints Safety Endpoints
Primary:
1. Freedom from device/system related complication at 6 months
2. Freedom from pressure sensor failure at 6 months
Secondary:
1. Freedom from device/system related complication at 12 and 24 months
2. Freedom from pressure sensor failure at 12 and 24 months
3. Pressure sensor failure rate throughout the study
4. Frequency of serious adverse events throughout the study
5. Frequency of implant procedure and procedure related adverse
events and serious adverse events
6. Phase II only: Incidence of serious adverse events at 12 months
Effectiveness Endpoints
Primary
Phase I: The primary efficacy endpoint is a composite of HF events (HF
hospitalizations or urgent HF visits) or deaths from cardiovascular disease
(CVD). Statistical analysis will be based on negative binomial regression, with the log follow-up time as an offset term, to descriptively assess event rates through 6 months. Results will be displayed using a cumulative event count curve. This analysis is intended for descriptive purposes, and no formal hypothesis testing, or control of Type I error will be performed
Follow-up Visits and Length of Follow-up 3, 6, 12, 18, 24, 36, 48, and 60 months after the study initiation


PROACTIVE-HF Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/19/2024 12/18/2024 On Time
1 year report 06/20/2025    
2 year report 06/20/2026    
3 year report 06/20/2027    
4 year report 06/19/2028    
5 year report 06/19/2029    


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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