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Prospective, single-arm, multi-center, continued access study 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-implantation, 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.
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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 |
|---|---|---|
| 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 |
| Primary Effectiveness Endpoint | Acceptable hemodynamic performance at 6 months post-valve implantation, defined as a mean RVOT gradient <=40 mmHg and less than moderate pulmonary regurgitation by transthoracic echo (TTE) as assessed by the Echocardiography Core Laboratory (ECL), and no Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch, as assessed by the CEC. | 6 Months post-valve implantation |
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| Measure | Description | Time Frame |
|---|---|---|
| Other Safety Outcome - Freedom from a device-related complication post-valve implantation - composite | Freedom from a device-related complication post-valve implantation - CEC Adjudicated. The following composite safety outcome will be evaluated at 6 months, and annually through 10 years post-valve implantation. The composite outcome includes device-related:
|
Inclusion Criteria:
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:
Subject requires valve replacement in a non-pulmonary position.
Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years).
Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
Subject has a known history of pulmonary atresia and major aortopulmonary collaterals.
Subject has significant peripheral pulmonary artery stenosis.
Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
Subject has active endocarditis or a history of infective endocarditis.
Subject has a known history of renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg/dL within 60 days prior to the Screening Visit, or has end-stage renal disease.
Subject has a known history of leukopenia (defined as a white blood cell [WBC] count <3.5 x 103/µL).
Subject has a known history of acute or chronic anemia (defined as hemoglobin [Hgb] <10.0 g/dl or 6 mmol/L).
Subject has a known history of thrombocytopenia (defined as platelet count <50 x 103/µL).
Subject has a known history of hypersensitivity to anticoagulants and antiplatelet drugs.
Subject has a known history of autoimmune disease or receives immunosuppressant and/or immunostimulant drugs, and the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes.
Subject needs emergency cardiac or vascular surgery or intervention.
Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.
Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.
Subject or parent/legal representative refuses blood transfusions.
Subject has medical, social, or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.
Subject is participating in an investigational study of a new drug, biologic, or device at the time of study screening.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie-Charlotte Hofferberth, MD | Contact | +1 (617) 390-6468 | shofferberth@autusvalve.com | |
| Paul Mehoudar, MS | Contact | +1 (510) 409-2255 | pmehoudar@autusvalve.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States | ||
| Children's Hospital Colorado |
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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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| 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome -Mortality | The following measure will be evaluated by an independent Clinical Events Committee: • 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: • 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: • Thromboembolism | 30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation |
| Other Safety Outcome - Other Cardiac or Valve Intervention | The following measure will be evaluated by an independent Clinical Events Committee: • Other cardiac or valve intervention (surgical or transcatheter) | 30 days, 6 months and annually through a minimum of 10 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: • 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: • 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: • 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: • 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 Frame Fracture | Independent Medical Reviewers will review post-implant chest x-rays to assess for valve/stent frame fractures. | 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 Dimension | Right ventricular (RV) dimension 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 - Right Ventricular Strain | Right ventricular (RV) measures 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 Ejection Fraction | Left ventricular (LV) ejection fraction 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 - Left Ventricular Strain | Left ventricular (LV) 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, using the following classification scale, where a lower class indicates reduced or no symptoms.
| 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 - The Pediatric Qualify of Life Inventory (PedsQL) - Cardiac Module. | The Pediatric Qualify of Life Inventory (PedsQL) Cardiac Module will be administered by Site Personnel. Scores range between 0 and 100. | 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 Effectiveness Outcome - The Pediatric Qualify of Life Inventory (PedsQL) - Generic Core Scale | The Pediatric Qualify of Life Inventory (PedsQL) Generic Core Scale will be administered by Site Personnel. Scores range between 0 and 100. | 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 |
| 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 |
| 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 |