Autus Valve Pivotal Study

NCT05006404 | Active Not Recruiting DMC FDA Device

• 1 other identifier: AUT-CP-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 12

Brief Summary

Prospective, single-arm, multi-center study to evaluate safety and effectiveness 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-implant, 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. 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.

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (2)

• Valve Implantation 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: * Death; * Valve thrombosis requiring intervention; * Symptomatic thromboembolism.

  30 Days post-valve implantation

• Valve Implantation Primary Effectiveness Endpoint

  Acceptable hemodynamic performance at 6 months post-valve implantation, as assessed by the Echocardiography Core Laboratory or Clinical Events Committee, defined as: * A mean RVOT gradient less than or equal to 40 mmHg and * Less than moderate pulmonary regurgitation by transthoracic echo and * No Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch.

  6 Months post-valve implantation

Other Outcomes (21)

• Other Safety Outcome - Composite

  6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation

• Other Safety Outcome - Mortality

  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

  30 days, 6 months, and annually through a minimum of 10 years and up to 11 years post-valve implantation

Study Arms (1)

Autus Valve Arm

EXPERIMENTAL

Pulmonary Valve Replacement Surgery with the Autus Valve

Device: Pulmonary Valve Replacement Surgery

Interventions

Pulmonary Valve Replacement Surgery DEVICE

Pulmonary valve replacement surgery with the Autus Valve

Autus Valve Arm

Eligibility Criteria

• Age: 18 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Candidates will be excluded from the study if any of the following conditions are met:
• 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 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 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 leukopenia (defined as a white blood cell (WBC) count \<3.5 x 103/µL)
• Subject has acute or chronic anemia (defined as hemoglobin (Hgb) \<10.0 g/dl or 6 mmol/L).
• Subject has thrombocytopenia (defined as platelet count \<50 x 103/µL.
• Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.
• 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.
• Subject needs emergency cardiac or vascular surgery or intervention.

Sponsors & Collaborators

• Autus Valve Technologies, Inc.: lead

Study Sites (12)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan - Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital

New York, New York, 10032, United States

Location

Duke University

Durham, North Carolina, 27703, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Utah - Intermountain Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (1)

• Galantowicz ME, Stiver CA, Barry OM, Bacha EA, Farooqi KM, Marx GR, Porras D, Baird CW, Armstrong AK. Novel size-adjustable pulmonary valve US early feasibility study: One-year outcomes. J Thorac Cardiovasc Surg. 2025 Dec;170(6):1739-1746. doi: 10.1016/j.jtcvs.2025.07.035. Epub 2025 Jul 31.

  PMID: 40752778 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sophie-Charlotte Hofferberth, MD

  Autus Valve Technologies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 16, 2021
• Study Start: February 5, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 5, 2036
• Last Updated: March 9, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)