Evaluation of the Autus Size-Adjustable Valve for pediatric pulmonary valve replacement

Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study

This study is testing a new adjustable heart valve for kids needing surgery to replace their pulmonary valve to see if it works safely and effectively as they grow.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Months to 16 Years
• Sex: All
• Sponsor: Autus Valve Technologies, Inc. (Industry-sponsored)
• Locations: 12 sites (Los Angeles, California and 11 other locations)
• Trial ID: NCT05006404 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years who require surgical pulmonary valve replacement. It is a prospective, single-arm, multi-center study where the valve can be expanded pre-implant to match the patient's body size and post-implant via balloon dilation to accommodate growth. Participants will be monitored at various intervals, including immediately post-implant, at discharge, and annually for up to 10 years to assess valve performance and patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 18 months to 16 years with severe pulmonary stenosis or significant pulmonary regurgitation who are recommended for surgical pulmonary valve replacement.

Not a fit: Patients who do not require surgical pulmonary valve replacement or are outside the age range of 18 months to 16 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this could provide a more adaptable and long-lasting solution for children with congenital heart disease requiring pulmonary valve replacement.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in valve replacement techniques for congenital heart disease, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.

1. Age 18 months to 16 years.
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:

Candidates will be excluded from the study if any of the following conditions are met:

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.

Where this trial is running

Los Angeles, California and 11 other locations

• Children's Hospital Los Angeles — Los Angeles, California, United States (Recruiting)
• Children's Hospital Colorado — Aurora, Colorado, United States (Recruiting)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
• Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Recruiting)
• Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
• University of Michigan - Mott Children's Hospital — Ann Arbor, Michigan, United States (Recruiting)
• Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital — New York, New York, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• University of Utah - Intermountain Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
• Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)

Study contacts

• Study coordinator: Sophie-Charlotte Hofferberth, MD.

Conditions Congenital Heart Disease