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| General |
| Study Status |
Progress Adequate |
| Application Number |
P180036 / PAS001 |
| Study Name |
OPTIMIZER System PAS
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Detailed Study Protocol Parameters |
| Study Design Description |
Prospective, non-randomized, multi-center, single-arm open label study to provide long-term safety and effectiveness data.
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| Study Population Description |
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 |
The study is powered for the safety endpoint defined as a composite adverse event count including both short-term procedural complications and long-term device complications. The proportion of patients who are free of procedural and device complications will be compared to an objective performance criterion. 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. This calculation is based on a one-sided Type I error of 0.025. With 589 evaluable patients at 1 year, if the observed complication free rate is as low as 0.79 then the null hypothesis will be rejected. 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.
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| Data Collection |
Safety: Demonstrate that the OPTIMIZER Smart is safe to use, by assessing the rate of device- or procedure-related complications.
Effectiveness: Demonstrate that CCM therapy improves quality of life (QOL), the functional status of NYHA III patients. In addition, assess CCM effect on left ventricular ejection fraction (LVEF),end-systolic volume (ESV), NT-proBNP and QRS Duration.
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| Follow-up Visits and Length of Follow-up |
36 months
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| Interim or Final Data Summary |
| Interim Safety Information |
Insufficient data to provide interim results.
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| Actual Number of Patients Enrolled |
1
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| Actual Number of Sites Enrolled |
3
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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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