Congenital Heart DiseaseNCT07466745
Autus Valve Continued Access Study (CAS)
A study testing Pulmonary Valve Replacement Surgery in people with Congenital Heart Disease, run by Edwards Lifesciences at 1 site in United States.
Trial 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. 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
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2026to 30 Apr 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
- 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);
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- 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
- 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).
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- 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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Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan - Mott Children's Hospital
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- 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.
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.
Measured: 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.
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 posted12 Mar 2026
- Study start27 Jul 2026
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Apr 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 4 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
- NCT07466745
- Sponsor's protocol ID
- AUT-CP-002
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 Continued Access Study
- ClinicalTrials.gov ID
- NCT07466745
- Acronym / sponsor ID
- AUT-CP-002
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Apr 2036 (estimated)
- First posted
- 12 Mar 2026 (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, 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 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 (11 listed)
- 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:
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 a known history of 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
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.
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.
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.
- 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.
1 site 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 1 site 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 11 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 1 site 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?
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?
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.