Autus Valve Continued Access Study (CAS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Device: Pulmonary Valve Replacement Surgery

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie-Charlotte Hofferberth, MD; Phone Number: +1 (617) 390-6468; Email: shofferberth@autusvalve.com
• Study Contact Backup: Name: Paul Mehoudar, MS; Phone Number: +1 (510) 409-2255; Email: pmehoudar@autusvalve.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan - Mott Children's Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27703
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • University of Utah - Intermountain Primary Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.
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 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).
11. Subject has a known history of thrombocytopenia (defined as platelet count <50 x 103/µL).
12. Subject has a known history of hypersensitivity to anticoagulants and antiplatelet drugs.
13. 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.
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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autus Valve Arm; Pulmonary Valve Replacement Surgery with the Autus Valve	Device: Pulmonary Valve Replacement Surgery; Pulmonary valve replacement surgery with the Autus Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 reintervention;; Symptomatic thromboembolism.	30 Days post-valve implantation
Primary Effectiveness Endpoint	Acceptable hemodynamic performance at 6 months post-valve implantation, defined as a mean RVOT gradient <=40 mmHg and less than moderate pulmonary regurgitation by transthoracic echo (TTE) as assessed by the Echocardiography Core Laboratory (ECL), and no Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch, as assessed by the CEC.	6 Months post-valve implantation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Effectiveness Outcome - Valve Implant Acute Procedural Success	To meet the definition of success, all the parameters listed below must be achieved, as assessed by Sites using direct pressure measurements and/or transesophageal echo (TEE): RV to PA peak systolic pressure gradient <40 mmHg (direct pressure measurement);; None or trivial pulmonary regurgitation (assessed via TEE);; No paravalvular leak (assessed via TEE).	Immediately Post-Valve Implant Procedure
Other Effectiveness Outcome - Pulmonary Regurgitation Grade	Pulmonary regurgitation grade categorized as none, trivial, mild, moderate, severe as evaluated by the Echo Core Laboratory.	Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Pulmonary Stenosis Grade	Pulmonary stenosis grade categorized as none/trivial, mild, moderate, severe, as evaluated by the Echo Core Laboratory.	Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Post-Implant Valve Expansion Safety Outcome - Composite	Composite Endpoint: Freedom from device-related complication through 30 days post-valve expansion as adjudicated by an independent CEC: Death;; Extracorporeal membrane oxygenation (ECMO) support;; Unplanned intervention (surgical or transcatheter);; Major hemorrhage	30 days after each post-implant valve expansion procedure
Other Post-Implant Valve Expansion Effectiveness Outcome - Acute Procedural Success	To meet the definition of success, at least one of the parameters listed below must be achieved after each post-implant valve expansion is performed, assessed during the same catheterization procedure: RV to aortic systolic pressure ratio: ≤0.5.; Peak-to-peak RV to PA systolic pressure gradient: ≤15 mmHg;; Peak-to-peak RV to PA systolic pressure gradient: ≥50% reduction (pre vs post valve expansion).	Immediately after each post-implant valve expansion procedure
Other Post-Implant Valve Expansion Effectiveness Outcome - Hemodynamic Performance	Clinically acceptable hemodynamic performance at 6 months post-valve expansion procedure, as assessed by the Echo Core Laboratory via TTE, defined as: Less than moderate pulmonary regurgitation (PR) by Doppler echocardiography;; Transvalvular gradient (assessed by CW Doppler) at 6-months is lower than the pre-expansion gradient.	6 months after each post-implant valve expansion procedure
Other Safety Outcome - Freedom from a device-related complication post-valve implantation - composite	Freedom from a device-related complication post-valve implantation - CEC Adjudicated. The following composite safety outcome will be evaluated at 6 months, and annually through 10 years post-valve implantation. The composite outcome includes device-related: Death;; Valve thrombosis requiring intervention;; Symptomatic thromboembolism.	6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome -Mortality	The following measure will be evaluated by an independent Clinical Events Committee: • Mortality, including: all cause, cardiac-related, procedure-related and device-related	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	The following measure will be evaluated by an independent Clinical Events Committee: • Valve thrombosis	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Thromboembolism	The following measure will be evaluated by an independent Clinical Events Committee: • Thromboembolism	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Other Cardiac or Valve Intervention	The following measure will be evaluated by an independent Clinical Events Committee: • Other cardiac or valve intervention (surgical or transcatheter)	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Major Hemorrhage	The following measure will be evaluated by an independent Clinical Events Committee: • Major hemorrhage	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Endocarditis	The following measure will be evaluated by an independent Clinical Events Committee: • Endocarditis	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Hemolysis	The following measure will be evaluated by an independent Clinical Events Committee: • Hemolysis	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Device Explantation	The following measure will be evaluated by an independent Clinical Events Committee: • Device explantation	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Adverse Events (AE)	The following measure will be reported at 30 days, 6 months, and annually through 10 years post-valve implantation. Subjects that undergo valve expansion in year 10 after device implantation will be followed for an additional year. • Adverse events	30 days, 6 months and annually through a minimum of 10 years and up to 11 years post-valve implantation
Other Safety Outcome - Valve/Stent Frame Fracture	Independent Medical Reviewers will review post-implant chest x-rays to assess for valve/stent frame fractures.	Pre-discharge, 12 months, and annually through a minimum of 5 years and up to 6 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-discharge and at 12 months post-valve expansion.
Other Effectiveness Outcome - Right Ventricular Dimension	Right ventricular (RV) dimension will be evaluated by the Echo Core Laboratory.	Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Right Ventricular Strain	Right ventricular (RV) measures strain will be evaluated by the Echo Core Laboratory.	Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Left Ventricular Ejection Fraction	Left ventricular (LV) ejection fraction will be evaluated by the Echo Core Laboratory.	Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Left Ventricular Strain	Left ventricular (LV) strain will be evaluated by the Echo Core Laboratory.	Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - Modified Ross Functional Classification	Modified Ross Functional Class as assessed by the Site Investigators, using the following classification scale, where a lower class indicates reduced or no symptoms.; Class I Asymptomatic.; Class II Mild tachypnea or diaphoresis with feeding in infants. Dyspnea on exertion in older children.; Class III Marked tachypnea or diaphoresis with feeding in infants. Prolonged feeding times with growth failure. Marked dyspnea on exertion in older children.; Class IV Symptoms such as tachypnea, retractions, grunting, or diaphoresis at rest.	Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.
Other Effectiveness Outcome - The Pediatric Qualify of Life Inventory (PedsQL) - Cardiac Module.	The Pediatric Qualify of Life Inventory (PedsQL) Cardiac Module will be administered by Site Personnel. Scores range between 0 and 100.	Baseline, 6 months and annually through 10 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion.
Other Effectiveness Outcome - The Pediatric Qualify of Life Inventory (PedsQL) - Generic Core Scale	The Pediatric Qualify of Life Inventory (PedsQL) Generic Core Scale will be administered by Site Personnel. Scores range between 0 and 100.	Baseline, 6 months and annually through 10 years post-valve implantation. Subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion.

Collaborators and Investigators

• Sponsor: Autus Valve Technologies, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): April 30, 2036

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: AUT-CP-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes