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General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P230040 / PAS001 |
Date Original Protocol Accepted |
10/04/2024
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Date Current Protocol Accepted |
01/17/2025
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Study Name |
PROACTIVE-HF Study
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Device Name |
Cordella Pulmonary Artery Sensor System (CorPASS)
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Clinical Trial Number(s) |
NCT04089059
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General Study Protocol Parameters |
Study Design |
Randomized Clinical Trial
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Data Source |
New Data Collection
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Comparison Group |
Concurrent Control
|
Analysis Type |
Descriptive
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Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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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.
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Study Population |
Adults diagnosed with NYHA Class III Heart Failure at enrollment
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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
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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
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Follow-up Visits and Length of Follow-up |
3, 6, 12, 18, 24, 36, 48, and 60 months after the study initiation
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