~26 spots leftby Aug 2026

Pulmonary Valve Replacement for Congenital Heart Disease

Recruiting at 11 trial locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Autus Valve Technologies, Inc.
Must not be taking: Antibiotics, Anticoagulants, Antiplatelets, Immunosuppressants
Disqualifiers: Pulmonary hypertension, Renal insufficiency, Anemia, others
No Placebo Group
Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests a special heart valve that can grow with children who need a new pulmonary valve. The valve can be resized before and after it is placed in the heart, reducing the need for multiple surgeries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an active infection requiring antibiotics, you must wait 4 weeks after stopping them to be eligible.

What data supports the effectiveness of the treatment Autus Size-Adjustable Valve for Pulmonary Valve Replacement in Congenital Heart Disease?

The research on pulmonary valve replacements shows that transcatheter valve (TCV) procedures, which are similar to the Autus Valve, have been beneficial and durable over time, as seen in a study of 1823 valve replacements. This suggests that the Autus Valve, being a type of TCV, may also be effective in treating congenital heart disease.12345

Is the Pulsta valve safe for pulmonary valve replacement in humans?

The Pulsta valve has been used successfully in patients with severe pulmonary regurgitation, showing positive early results in terms of safety. It has been tested in patients with conditions like tetralogy of Fallot, and no major safety concerns have been reported in these studies.56789

How is the Autus Size-Adjustable Valve treatment different from other treatments for congenital heart disease?

The Autus Size-Adjustable Valve is unique because it can be adjusted in size, which may help address the common issue of geometric mismatch between the pulmonary and aortic valves in children, potentially improving the fit and function of the valve over time.12456

Research Team

SH

Sophie-Charlotte Hofferberth, MD

Principal Investigator

Autus Valve Technologies, Inc.

Eligibility Criteria

This trial is for pediatric patients aged 18 months to 16 years who need pulmonary valve replacement surgery and have a suitable body size for the Autus Valve. They must be able to attend follow-up visits, not have autoimmune diseases or infections, and not require other heart valve replacements soon.

Inclusion Criteria

I am either male or female.
My pulmonary artery is long enough for the device implant.
I have severe issues with my heart valves affecting lung blood flow.
See 6 more

Exclusion Criteria

I have kidney problems.
You are allergic to medications that prevent blood from clotting or reduce platelet activity.
You have low levels of white blood cells.
See 16 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical pulmonary valve replacement with the Autus Size-Adjustable Valve

Immediate post-implant to hospital discharge
In-hospital stay

Initial Follow-up

Participants are monitored for safety and effectiveness at 30 days, 6 months, and annually through 10 years post-valve implantation

10 years
30 days, 6 months, annually

Post-Implant Valve Expansion

Participants may undergo post-implant valve expansion via transcatheter balloon dilation to accommodate growth

Immediately post-expansion to 1 year
Immediately post-expansion, 6 months, 12 months

Extended Follow-up

Participants who undergo valve expansion in year 10 will be followed for an additional year

1 year

Treatment Details

Interventions

  • Autus Size-Adjustable Valve (Prosthetic Valve)
Trial OverviewThe study tests the safety and effectiveness of the Autus Size-Adjustable Valve in children requiring pulmonary valve replacement. The valve can be expanded before implantation and post-implant via balloon dilation to accommodate growth over time.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Autus Valve ArmExperimental Treatment1 Intervention
Pulmonary Valve Replacement Surgery with the Autus Valve

Find a Clinic Near You

Who Is Running the Clinical Trial?

Autus Valve Technologies, Inc.

Lead Sponsor

Trials
1
Recruited
50+

Findings from Research

A case study demonstrated that percutaneous pulmonary valve implantation (PPVI) using a 32 mm Myval valve was effective in treating severe biventricular dysfunction and enlargement due to chronic pulmonary regurgitation in a patient with congenital heart disease.
The Myval valve's design allowed successful implantation in a large and tortuous right ventricle outflow tract, which is typically challenging for other valve types, highlighting its potential for expanding treatment options in similar cases.
Pulmonary valve replacement in a large and tortuous right ventricle outflow tract with a 32 mm Myval valve under local anaesthesia: challenges and technical considerations: a case report.Houeijeh, A., Sudre, A., Juthier, F., et al.[2023]
In a study of 41 children who underwent the Ross procedure, significant mismatches between the diameters of the pulmonary and aortic valves did not prevent successful outcomes, indicating that the procedure can be safely performed even with such discrepancies.
At a median follow-up of 31 months, most patients (30 out of 38) experienced no or trivial regurgitation of the autograft, suggesting that technical factors during surgery are more critical for preventing regurgitation than the geometric mismatch itself.
Geometric mismatch of pulmonary and aortic anuli in children undergoing the Ross procedure: implications for surgical management and autograft valve function.Reddy, VM., McElhinney, DB., Phoon, CK., et al.[2016]
In a study of 37 patients who underwent pulmonary valve replacement (PVR) with biological prosthetic valves, there were no early valve-related deaths, and the 5-year survival rate was an impressive 95.1%.
The procedure significantly improved patients' functional status, with 91.8% of patients achieving NYHA class I status post-surgery, indicating better heart function and quality of life compared to only 54% preoperatively.
Midterm evaluation of biological prosthetic valves in the pulmonary position of grown-up patients.Vohra, HA., Whistance, RN., Baliulis, G., et al.[2012]

References

Pulmonary valve replacement in a large and tortuous right ventricle outflow tract with a 32 mm Myval valve under local anaesthesia: challenges and technical considerations: a case report. [2023]
Geometric mismatch of pulmonary and aortic anuli in children undergoing the Ross procedure: implications for surgical management and autograft valve function. [2016]
Midterm evaluation of biological prosthetic valves in the pulmonary position of grown-up patients. [2012]
The Ross operation: do native aortic, native pulmonary, and homograft pulmonary valve size and form differences influence results? [2004]
Pulmonary valve prostheses: patient's lifetime procedure load and durability. Evaluation of the German National Register for Congenital Heart Defects. [2022]
Extending the limits of the Ross procedure. [2019]
Long-term outcomes of pulmonary valve replacement in patients with repaired tetralogy of Fallot. [2021]
Bilateral branch pulmonary artery Pulsta valve implantation for treatment of large right ventricular outflow tract in a high-risk patient. [2022]
Early results of Pulsta® transcatheter heart valve in patients with enlarged right ventricular outflow tract and severe pulmonary regurgitation due to transannular patch. [2023]