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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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