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Autus Valve Continued Access Study (CAS) | Clinical Trials | Clareo Health

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Autus Valve Continued Access Study (CAS)

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

NCT07466745•Autus Valve Technologies, Inc.

Summary

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.

Eligibility

Age

1 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+1 more criteria

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 a known history of 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 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.
•9. Subject has a known history of leukopenia (defined as a white blood cell \[WBC\] count \<3.5 x 103/µL).
•10. Subject has a known history of acute or chronic anemia (defined as hemoglobin \[Hgb\] \<10.0 g/dl or 6 mmol/L).
+10 more criteria

Locations (10)

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

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

University of Utah - Intermountain Primary Children's Hospital

Salt Lake City, Utah, United States

Seattle Children's Hospital

Seattle, Washington, United States

Key Dates

Start Date

April 15, 2026

Primary Completion Date

October 30, 2027

Completion Date

April 30, 2036

Last Updated

March 12, 2026

Enrollment

ESTIMATED participants

Conditions

Congenital Heart Disease

Interventions

Pulmonary Valve Replacement Surgery

DEVICE

Contacts

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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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Autus Valve Continued Access Study (CAS)

Inclusion Criteria

Exclusion Criteria

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