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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180036 / PAS001 |
| Date Original Protocol Accepted |
03/21/2019
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| Date Current Protocol Accepted |
04/08/2025
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| Study Name |
OPTIMIZER Smart System PAS
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| Device Name |
OPTIMIZER Smart System
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| Clinical Trial Number(s) |
NCT01381172
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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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.
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| 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).
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| Sample Size |
up to 650 patients. No limit on sites.
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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
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| Interim or Final Data Summary |
| Interim Results |
Safety Results:
167 serious adverse events (SAEs) through 2 years were reported during the current period. Of these, 7 were considered either system- or procedure- related (4.2% of all SAEs). To date, there have been 29 lead dislodgements total (4.2% of total subject enrollment).
Primary Safety:
• 6.1% rate of procedure-related adverse events through 30 days or device-related adverse events through the end of 1 year
All-cause mortality:
• At 1-year, 90.90% Kaplan-Meier actual survival vs. 93.56% predicted mortality using Seattle Heart Failure Model (N=567)
• At 3-year, 78.10% Kaplan-Meier actual survival vs. 82.37% predicted mortality using Seattle Heart Failure Model (N=275)
Effectiveness Results:
MLWHF
• Baseline to 1-year: –16.9 ± 24.0 (N=482)
• Baseline to 2-year: –18.4 ± 25.0 (N=380)
NYHA Classification
• Baseline to 1-year: –0.9 ± 0.8 (N=503)
• Baseline to 2-year: –0.9 ± 0.8 (N=387)
LVEF (%)
• Baseline to 1-year: 2.9 ± 8.1 (N=219)
• Baseline to 2-year: 3.6 ± 9.0 (N=139)
LVESV (cm3)
• Baseline to 1-year: –13.8 ± 27.5 (N=219)
• Baseline to 2-year: –19.3 ± 30.0 (N=139)
NT-proBNP (pg/mL)
• Baseline to 1-year: 49.6 ± 5467 (N=449)
• Baseline to 2-year: –101 ± 3930 (N=355)
QRS width (ms)
• Baseline to 1-year: –1.0 ± 28.8 (N=346)
• Baseline to 2-year: –1.0 ± 36.5 (N=320)
Results displayed in Mean ± SD with number of subjects (N)
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| Actual Number of Patients Enrolled |
692
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| Actual Number of Sites Enrolled |
91
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| Patient Follow-up Rate |
1 Year: 510 actual follow up (FU) (92.1%), 64* deaths, 39 withdrawals*, 1 lost to FU*
2 Year: 395 actual FU (90.8%), 100 deaths*, 68* withdrawals, 3 lost to FU*
3 Year: 221 actual FU (86.3%), 125 deaths*, 78 withdrawals*, 13 lost to FU*
* denotes cumulative counts
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