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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 |
10/23/2024
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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 800 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
162 SAEs reported during the current period. Of these, 20 were considered system- or procedure-related. To date, 17 lead dislodgements and 1 lead fracture have occurred within 30 days of implant.
Primary Safety:
-5.9% rate of procedure-related SAEs through 30 days plus device-related SAEs through 1 year
All-cause mortality:
-At 1-year, 92.4% Kaplan-Meier actual survival vs 93.5% predicted mortality using Seattle Heart Failure Model, (N=350)
-At 3-year, 84.2% Kaplan-Meier actual survival vs 82.2% predicted mortality using Seattle Heart Failure Model, (N=29)
Effectiveness Results
MLWHF
- Baseline to 1-year: -18.1 -/+ 25.0 (N=279)
- Baseline to 2-year: -22.6 -/+ 25.0 (N=139)
NYHA Classification
- Baseline to 1-year: -0.9 -/+ 0.8 (N=289)
- Baseline to 2-year: -1.1 -/+ 0.8 (N=141)
LVEF (%)
- Baseline to 1-year: 3.3 -/+.8 (N=65)
- Baseline to 2-year: 6.2 -/+.9 (N=26)
LVESV (cm3)
- Baseline to 1-year: -15.1 -/+ 28.4 (N=65)
- Baseline to 2-year: -24.5 -/+ 31.8 (N=26)
NT-proBNP (pg/mL)
- Baseline to 1-year: 502.8 -/+ 3878 (N=249)
- Baseline to 2-year: -11.9 -/+ 1162 (N=132)
QRS width (ms)
- Baseline to 1-year: -1.8 -/+ 28.6 (N=138)
- Baseline to 2-year: 2.6 -/+ 32.2 (N=80)
Results displayed in Mean -/+ SD with number of subjects (N)
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| Actual Number of Patients Enrolled |
574
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| Actual Number of Sites Enrolled |
72
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| Patient Follow-up Rate |
1 Year: 303 actual follow-up (FU) (88.9%), 37 deaths*, 26 withdrawals*,
2 Year: 144 actual FU (86.7%), 50 deaths*, 34 withdrawals*, 1 lost to FU*
3 Year: 38 actual FU (77.8%), 54 deaths*, 37 withdrawals*, 1 lost to FU*
*cumulative
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