Congenital Heart DiseaseNCT05006404
Autus Valve Pivotal Study
A study testing Pulmonary Valve Replacement Surgery in people with Congenital Heart Disease, run by Edwards Lifesciences at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 16 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Pulmonary Valve Replacement Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 12 sitesUnited States
- Study dates
- 5 Feb 2024to 5 Feb 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Nationwide Children's Hospital
Columbus, Ohio, 43205
Duke University
Durham, North Carolina, 27703
Children's Hospital Los Angeles
Los Angeles, California, 90027
Columbia University Irving Medical Center/New York Presbyterian Morgan Stanley Children's Hospital
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Utah - Intermountain Primary Children's Hospital
Salt Lake City, Utah, 84113
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study
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
- Being tested
- Pulmonary Valve Replacement Surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Valve Replacement SurgeryDevice
Pulmonary valve replacement surgery with the Autus Valve
| Study group | Role | What they receive |
|---|---|---|
| Autus Valve Arm | Experimental | Pulmonary Valve Replacement Surgery with the Autus Valve Receives: Device: Pulmonary Valve Replacement Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Months post-valve implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start5 Feb 2024
- Primary completion24 Aug 2026
- Study completion5 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006404
- Sponsor's protocol ID
- AUT-CP-001
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2021
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40752778
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal Study
- ClinicalTrials.gov ID
- NCT05006404
- Acronym / sponsor ID
- AUT-CP-001
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 24 Aug 2026 (actual)
- Study completion
- 5 Feb 2036 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autus Valve Arm | Experimental | Device: Pulmonary Valve Replacement SurgeryPulmonary Valve Replacement Surgery with the Autus Valve |
Who may qualify
- Ages
- 18 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Valve Replacement SurgeryPulmonary valve replacement surgery with the Autus Valve | Device | Autus Valve Arm |
Primary outcome
Valve Implantation 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 intervention; * Symptomatic thromboembolism.
Valve Implantation Primary Effectiveness Endpoint
Time frame: 6 Months post-valve implantation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 40752778Galantowicz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Valve Replacement Surgery in people with Congenital Heart Disease, run by Edwards Lifesciences at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valve Implantation Primary Safety Endpoint (time frame: 30 Days post-valve implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006404, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.