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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: >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.
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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
164 SAEs were reported during the report period. Of these, 17 were considered either system- or procedure- related (10.37% of all SAEs). To date, there have been 26 lead dislodgements total (4.0% of total subject enrollment).
Primary Safety:
• 7.3% rate of device-related adverse events (SADEs; N=60 patients out of N=654 total enrollment)
All-cause mortality:
• At 1-year, 91.80% Kaplan-Meier actual survival vs. 93.56% predicted mortality using Seattle Heart Failure Model (N=653)
• At 3-year, 81.50% Kaplan-Meier actual survival vs. 82.36% predicted mortality using Seattle Heart Failure Model (N=380)
Effectiveness Results
MLWHF
• Baseline to 1-year: -17.1 ± 24.4 (N=420)
• Baseline to 2-year: -19.0 ± 24.9 (N=261)
NYHA Classification
• Baseline to 1-year: -0.9 ± 0.8 (N=434)
• Baseline to 2-year: -19.0 ± 24.9 (N=261)
LVEF (%)
• Baseline to 1-year: 2.9 ± 8.0 (N=196)
• Baseline to 2-year: 3.4 ± 8.8 (N=98)
LVESV (cm3)
• Baseline to 1-year: -13.1 ± 27.6 (N=196)
• Baseline to 2-year: -17.2 ± 28.9 (N=98)
NT-proBNP (pg/mL)
• Baseline to 1-year: 18.9 ± 5800 (N=392)
• Baseline to 2-year: 162.2 ± 1964 (N=240)
QRS width (ms)
• Baseline to 1-year: -0.3 ± 29.4 (N=280)
• Baseline to 2-year: -0.8 ± 39.3 (N=201)
Results displayed in Mean ± SD with number of subjects (N)
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| Actual Number of Patients Enrolled |
654
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| Actual Number of Sites Enrolled |
77
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| Patient Follow-up Rate |
1 Year: 447 actual follow up (FU) (90.5%), 52* deaths, 35 withdrawals*
2 Year: 268 actual FU (88.7%), 77 deaths*, 53* withdrawals, 3 lost to FU*
3 Year: 118 actual FU (80.3%), 88 deaths*, 59 withdrawals*, 4 lost to FU*
* denotes cumulative counts
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