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NCT Number: NCT07466745

Autus Valve Continued Access Study (CAS)

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.

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Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

18 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Pulmonary Valve Replacement Surgery

Device

Pulmonary valve replacement surgery with the Autus Valve

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 30 Days post-valve implantation

    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.

  2. Primary Effectiveness Endpoint

    Time frame: 6 Months post-valve implantation

    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.

Other outcomes

  1. Other Safety Outcome - Freedom from a device-related complication post-valve implantation - composite

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

    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.

  2. Other Safety Outcome -Mortality

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Mortality, including: all cause, cardiac-related, procedure-related and device-related

  3. Other Safety Outcome - Valve thrombosis

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Valve thrombosis

  4. Other Safety Outcome - Thromboembolism

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Thromboembolism

  5. Other Safety Outcome - Other Cardiac or Valve Intervention

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Other cardiac or valve intervention (surgical or transcatheter)

  6. Other Safety Outcome - Major Hemorrhage

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Major hemorrhage

  7. Other Safety Outcome - Endocarditis

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Endocarditis

  8. Other Safety Outcome - Hemolysis

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Hemolysis

  9. Other Safety Outcome - Device Explantation

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

    The following measure will be evaluated by an independent Clinical Events Committee:

    • Device explantation

  10. Other Safety Outcome - Adverse Events (AE)

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

    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

  11. Other Safety Outcome - Valve/Stent Frame Fracture

    Time frame: 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.

    Independent Medical Reviewers will review post-implant chest x-rays to assess for valve/stent frame fractures.

  12. Other Effectiveness Outcome - Valve Implant Acute Procedural Success

    Time frame: Immediately Post-Valve Implant Procedure

    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).

  13. Other Effectiveness Outcome - Pulmonary Regurgitation Grade

    Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    Pulmonary regurgitation grade categorized as none, trivial, mild, moderate, severe as evaluated by the Echo Core Laboratory.

  14. Other Effectiveness Outcome - Pulmonary Stenosis Grade

    Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    Pulmonary stenosis grade categorized as none/trivial, mild, moderate, severe, as evaluated by the Echo Core Laboratory.

  15. Other Effectiveness Outcome - Right Ventricular Dimension

    Time frame: Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    Right ventricular (RV) dimension will be evaluated by the Echo Core Laboratory.

  16. Other Effectiveness Outcome - Right Ventricular Strain

    Time frame: Baseline, 30 days, 6 months, and annually through 5 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    Right ventricular (RV) measures strain will be evaluated by the Echo Core Laboratory.

  17. Other Effectiveness Outcome - Left Ventricular Ejection Fraction

    Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    Left ventricular (LV) ejection fraction will be evaluated by the Echo Core Laboratory.

  18. Other Effectiveness Outcome - Left Ventricular Strain

    Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    Left ventricular (LV) strain will be evaluated by the Echo Core Laboratory.

  19. Other Effectiveness Outcome - Modified Ross Functional Classification

    Time frame: Baseline, 30 days, 6 months, and annually through 10 years post-valve implant and 30 days, 6 months, and 12 months post-valve expansion.

    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.

  20. Other Effectiveness Outcome - The Pediatric Qualify of Life Inventory (PedsQL) - Cardiac Module.

    Time frame: 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.

    The Pediatric Qualify of Life Inventory (PedsQL) Cardiac Module will be administered by Site Personnel. Scores range between 0 and 100.

  21. Other Effectiveness Outcome - The Pediatric Qualify of Life Inventory (PedsQL) - Generic Core Scale

    Time frame: 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.

    The Pediatric Qualify of Life Inventory (PedsQL) Generic Core Scale will be administered by Site Personnel. Scores range between 0 and 100.

  22. Other Post-Implant Valve Expansion Safety Outcome - Composite

    Time frame: 30 days after each post-implant valve expansion procedure

    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

  23. Other Post-Implant Valve Expansion Effectiveness Outcome - Acute Procedural Success

    Time frame: Immediately after each post-implant valve expansion procedure

    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).

  24. Other Post-Implant Valve Expansion Effectiveness Outcome - Hemodynamic Performance

    Time frame: 6 months after each post-implant valve expansion procedure

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jennie Wurgler, MS, ACRP CP

CONTACT

[email protected]

949-250-2500

Paul Mehoudar, MS

CONTACT

[email protected]

+1 (510) 409-2255

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2036
First posted
Mar 12, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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