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| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P180036 / PAS001 |
| Date Original Protocol Accepted |
03/21/2019
|
| Date Current Protocol Accepted |
09/06/2022
|
| Study Name |
OPTIMIZER System PAS
|
| Device Name |
OPTIMIZER Smart System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
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| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
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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 |
Prospective, non-randomized, multi-center, single-arm open label study to provide long-term safety and effectiveness data.
|
| Study Population |
Patients to be included will have NYHA functional class III symptoms and reduced (HFrEF) or moderately reduced (HFmrEF) ejection fraction (25-45% inclusive and are not indicated for Cardiac Synchronization Therapy (CRT).
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| Sample Size |
No. of subjects: With 620 patients (589 evaluable) at one year, the study will have 90% power to demonstrate a complication free rate greater than 0.75 if the assumed complication free rate is 0.81 allowing for 5% lost to follow-up at 1 year. To account for a 20% expected attrition rate through 3 years, 620 subjects will be enrolled in the PAS study to ensure 500 subjects complete the study. With 500 patients, if the observed complication free rate at the end of the study is as low as 0.79 then a similar test of the null hypothesis would be rejected. No. of sites: 54 ready for enrollment Sites location: US
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| Key Study Endpoints |
Safety Endpoints
The powered safety endpoint is a composite incidence of device- or procedure-related complication free rate at 12 months post-index implantation procedure compared to a performance goal of 75%.
1. Procedure related complications occurring through the end of 30 days following the index procedure.
2. Optimizer device-related complications occurring through the end of 1-year following the index procedure.
Observed mortality will be compared to predicted mortality for the patient group according to the Seattle Heart Failure Model (SHFM) at 1 year and 3 years post-implant.
Effectiveness Endpoints
Change in QOL, as measured by MLWHFQ, from baseline to 9 months, 2-years and 3-years following index implantation procedure.
Clinician assessment of functional class. A one – class change in functional class at 9-months, 2-years and 3-years following index implantation.
Change in LVEF and ESV at 9-months, 2-years and 3-years following index implantation.
Change in NT-proBNP at 9-months, 2-years and 3-years following index implantation.
Change in QRS duration at 9-months, 2-years and 3-years following index implantation.
Additional: An assessment of the incidence of Optimizer device-related “complications” (SADEs) and “observations” (ADEs) occurring during the 3-year period following the index procedure.
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| Follow-up Visits and Length of Follow-up |
Followed ups are scheduled:
9-month, 2-year and 3-year
3 years
|
| Interim or Final Data Summary |
| Interim Results |
Insufficient data to provide interim results.
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| Actual Number of Patients Enrolled |
84
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| Actual Number of Sites Enrolled |
34
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| Patient Follow-up Rate |
N/A
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| Study Strengths & Weaknesses |
Insufficient data to provide an opinion on Strengths and Weaknesses.
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