Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-02-05
2036-02-05
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autus Valve Arm
Pulmonary Valve Replacement Surgery with the Autus Valve
Pulmonary Valve Replacement Surgery
Pulmonary valve replacement surgery with the Autus Valve
Interventions
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Pulmonary Valve Replacement Surgery
Pulmonary valve replacement surgery with the Autus Valve
Eligibility Criteria
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Inclusion Criteria
2. Male or female.
3. Subject has a native or repaired right ventricular outflow tract.
4. Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
5. Subject has at least one of the following echocardiographic findings:
1. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
2. Moderate or greater pulmonary regurgitation;
3. Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
6. Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
7. Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
8. 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
1. Subject requires valve replacement in a non-pulmonary position.
2. 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).
3. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
4. Subject has pulmonary atresia and major aortopulmonary collaterals.
5. Subject has significant peripheral pulmonary artery stenosis.
6. Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
7. Subject has active endocarditis or a history of infective endocarditis.
8. Subject has 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.
9. Subject has leukopenia (defined as a white blood cell (WBC) count \<3.5 x 103/µL)
10. Subject has acute or chronic anemia (defined as hemoglobin (Hgb) \<10.0 g/dl or 6 mmol/L).
11. Subject has thrombocytopenia (defined as platelet count \<50 x 103/µL.
12. Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.
13. Subject has a known autoimmune disease or receives immunosuppressant and/or immunostimulant drugs that the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes.
14. Subject needs emergency cardiac or vascular surgery or intervention.
15. Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.
16. Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.
17. Subject or parent/legal representative refuses blood transfusions.
18. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.
19. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening.
18 Months
16 Years
ALL
No
Sponsors
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Autus Valve Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sophie-Charlotte Hofferberth, MD
Role: STUDY_DIRECTOR
Autus Valve Technologies, Inc.
Locations
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Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, United States
Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, United States
Duke University
Durham, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
University of Utah - Intermountain Primary Children's Hospital
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AUT-CP-001
Identifier Type: -
Identifier Source: org_study_id
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