Autus Valve Continued Access Study (CAS)

Official title

Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Continued Access Study

Overview

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.

Interventions

• Device Pulmonary Valve Replacement Surgery
  Pulmonary valve replacement surgery with the Autus Valve

Primary outcome measures

• Primary Safety Endpoint [Time frame: 30 Days post-valve implantation]
• Primary Effectiveness Endpoint [Time frame: 6 Months post-valve implantation]

Eligibility criteria

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:

• Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
• Moderate or greater pulmonary regurgitation;
• Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
• 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 10 centers

• Children's Hospital Los Angeles — Los Angeles
• Children's Hospital Colorado — Aurora
• Children's Healthcare of Atlanta — Atlanta
• Boston Children's Hospital — Boston
• University of Michigan - Mott Children's Hospital — Ann Arbor
• Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's — New York
• Duke University — Durham
• Nationwide Children's Hospital — Columbus
• … and 2 more centers

Identifiers

NCT: NCT07466745 · AUT-CP-002

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗