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Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implant, at hospital discharge, 30 days, 6 months, and annually through 10 years.
The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autus Valve Arm | Experimental | Pulmonary Valve Replacement Surgery with the Autus Valve |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Valve Replacement Surgery | Device | Pulmonary valve replacement surgery with the Autus Valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Valve Implantation Primary Safety Endpoint | Composite Endpoint: Freedom from a device-related complication through 30 days post-valve implantation as adjudicated by an independent Clinical Events Committee (CEC), including:
| 30 Days post-valve implantation |
| Valve Implantation Primary Effectiveness Endpoint | Acceptable hemodynamic performance at 6 months post-valve implantation, as assessed by the Echocardiography Core Laboratory or Clinical Events Committee, defined as:
| 6 Months post-valve implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Other Safety Outcome - Composite | The following other safety outcome will be evaluated at 6 months, and annually through 10 years post-valve implantation by an independent Clinical Events Committee. The composite outcome includes device-related:
| 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation |
Inclusion Criteria:
Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.
Age 18 months to 16 years.
Male or female.
Subject has a native or repaired right ventricular outflow tract.
Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
Subject has at least one of the following echocardiographic findings:
Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
Subject and parent/legal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits.
Exclusion Criteria:
Candidates will be excluded from the study if any of the following conditions are met:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie-Charlotte Hofferberth, MD | Edwards Lifesciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40752778 | Derived | Galantowicz ME, Stiver CA, Barry OM, Bacha EA, Farooqi KM, Marx GR, Porras D, Baird CW, Armstrong AK. Novel size-adjustable pulmonary valve US early feasibility study: One-year outcomes. J Thorac Cardiovasc Surg. 2025 Dec;170(6):1739-1746. doi: 10.1016/j.jtcvs.2025.07.035. Epub 2025 Jul 31. |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Other Safety Outcome - Mortality | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Mortality, including: all cause, cardiac-related, procedure-related and device-related | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Valve Thrombosis | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Valve thrombosis | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Thromboembolism | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Thromboembolism | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Cardiac or Valve Intervention | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Other cardiac or valve intervention (surgical or transcatheter) | 30 days, 6 months, and annually through a minimum of 510 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Major Hemorrhage | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Major hemorrhage | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Endocarditis | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Endocarditis | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Hemolysis | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Hemolysis | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Device Explantation | The following measure will be evaluated by an independent Clinical Events Committee at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Device explantation | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Adverse Events (AE) | The following measure will be reported at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Adverse events | 30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Valve/Stent Fracture | An independent Medical Reviewer will review post-implant chest x-rays to assess for valve/stent fracture. Chest x-rays will be performed at the following timepoints: post-valve implantation at hospital discharge, and annually through 5 years post-valve implantation. If a post-implant valve expansion procedure is performed, chest x-rays will be performed at hospital discharge and 12 months post-procedure. | pre-discharge, 12 months, and annually through a minimum of 5 years and up to 6 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-discharge and at 12 months post-valve expansion. |
| Other Effectiveness Outcome - Valve Implant Acute Procedural Success | To meet the definition of success, all the parameters listed below must be achieved, as assessed by Sites using direct pressure measurements and/or transesophageal echo (TEE):
| Immediately Post-Valve Implant Procedure |
| Other Effectiveness Outcome - Pulmonary Regurgitation Grade | Pulmonary regurgitation grade categorized as none, trivial, mild, moderate, severe as evaluated by the Echo Core Laboratory. | Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion. |
| Other Effectiveness Outcome - Pulmonary Stenosis Grade | Pulmonary stenosis grade categorized as none/trivial, mild, moderate, severe, as evaluated by the Echo Core Laboratory. | Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion. |
| Other Effectiveness Outcome - Right Ventricular Measures | Right ventricular (RV) measures, including RV dimension and strain will be evaluated by the Echo Core Laboratory. | Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion. |
| Other Effectiveness Outcome - Left Ventricular Measures | Left ventricular (LV) measures, including LV ejection fraction and strain will be evaluated by the Echo Core Laboratory. | Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion. |
| Other Effectiveness Outcome - Modified Ross Functional Classification | Modified Ross Functional Class as assessed by the Site Investigators | Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion. |
| Other Effectiveness Outcome - PedsQL - Cardiac Module | The Pediatric Qualify of Life Inventory (PedsQL) Cardiac Module will be administered by Site Personnel. | Baseline, 6 months and annually through 10 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion. |
| Other Post-Implant Valve Expansion Safety Outcome - Composite | Composite Endpoint: Freedom from device-related complication through 30 days post-valve expansion as adjudicated by an independent CEC:
| 30 days after each post-implant valve expansion procedure |
| Other Post-Implant Valve Expansion Effectiveness Outcome - Acute Procedural Success | To meet the definition of success, at least one of the parameters listed below must be achieved after each post-implant valve expansion is performed, assessed during the same catheterization procedure:
| Immediately after each post-implant valve expansion procedure |
| Other Post-Implant Valve Expansion Effectiveness Outcome - Hemodynamic Performance | Clinically acceptable hemodynamic performance at 6 months post-valve expansion procedure, as assessed by the Echo Core Laboratory via TTE, defined as:
| 6 months after each post-implant valve expansion procedure |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan - Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| Duke University | Durham | North Carolina | 27703 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Utah - Intermountain Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |