Pulmonary Valve Replacement for Congenital Heart Disease

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen by Steven Colan, MD.

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 2 4 5 6}

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.

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.

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 Overview The 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

Group I: Autus Valve Arm Experimental Treatment 1 Intervention

Pulmonary Valve Replacement Surgery with the Autus Valve

Autus Size-Adjustable Valve is already approved in United States for the following indications:

🇺🇸 Approved in United States as Autus Valve for:

• Pediatric pulmonary valve disease
• Right-sided congenital heart diseases
• Pulmonary stenosis
• Tetralogy of Fallot

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Duke University Durham, NC

Children's Hospital of Philadelphia Philadelphia, PA

Seattle Children's Hospital Seattle, WA

Children's Hospital Colorado Aurora, CO

More Trial Locations

Who Is Running the Clinical Trial?

Autus Valve Technologies, Inc. Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

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] Pulmonary valve replacement in patients with congenital heart diseases and heart failure is challenging.

2. United States pubmed.ncbi.nlm.nih.gov

Geometric mismatch of pulmonary and aortic anuli in children undergoing the Ross procedure: implications for surgical management and autograft valve function. [2016] There is often substantial mismatch between the diameters of the pulmonary and aortic anuli in young patients with systemic outflow tract disease. To implant the autologous pulmonary valve in the aortic position under such circumstances, it is necessary to adapt the geometry of the systemic outflow tract. The effects of such adaptations on autograft function in children are not well known.

3. Germany pubmed.ncbi.nlm.nih.gov

Midterm evaluation of biological prosthetic valves in the pulmonary position of grown-up patients. [2012] To examine the midterm clinical outcome of pulmonary valve replacement (PVR) with prosthetic valves.

4. Germany pubmed.ncbi.nlm.nih.gov

The Ross operation: do native aortic, native pulmonary, and homograft pulmonary valve size and form differences influence results? [2004] The pulmonary autograft approaches the ideal aortic valve substitute but numerous technical modifications are debated. The valves involved often differ in diameter and shape of the recipient annulus. We previously reported simplified surgical rules and early results of 52 patients and here we extend the report to 76 patients and analyze the mid-term results with respect to valve mismatch.

5. England pubmed.ncbi.nlm.nih.gov

Pulmonary valve prostheses: patient's lifetime procedure load and durability. Evaluation of the German National Register for Congenital Heart Defects. [2022] We evaluated 4384 procedures performed between 1957 and 2018, collected in the National Register for Congenital Heart Defects, conducted on 997 patients with 1823 pulmonary valve replacements (PVRs), including 226 implanted via catheter [transcatheter valve (TCV)]. Main study targets are as follows: TCV benefit, valve type durability, decade-wise treatment changes and procedure frequencies over the lifetime of a PVR patient.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Extending the limits of the Ross procedure. [2019] The potential for growth and the proven long-term durability of the native pulmonary valve make it ideal for replacement of the diseased aortic valve, especially in growing children. The use of the autologous pulmonary valve can be further extended to patients with complex left ventricular outflow tract obstruction and to neonates and infants.

7. Germany pubmed.ncbi.nlm.nih.gov

Long-term outcomes of pulmonary valve replacement in patients with repaired tetralogy of Fallot. [2021] The objectives of this study were to evaluate long-term outcomes of pulmonary valve replacement (PVR) in patients with repaired tetralogy of Fallot (TOF) and to identify the factors associated with adverse clinical events (ACEs).

8. United States pubmed.ncbi.nlm.nih.gov

Bilateral branch pulmonary artery Pulsta valve implantation for treatment of large right ventricular outflow tract in a high-risk patient. [2022] Percutaneous pulmonary valve implantation (PPVI) has been implemented as a novel alternative strategy to surgical pulmonary valve replacement. However, PPVI has an inevitable limitation: the large right ventricular outflow tract (RVOT) lesions exhibit variable geometry and significant pulmonary regurgitation (PR). To overcome this limitation, bilateral branch pulmonary artery (PA) valve implantations using Melody or Sapien valves have been attempted and have shown a reduction in right ventricular volume with clinical benefits in the intermediate term. Nevertheless, these trials also have constraints of large branch PA size. Recently, a feasibility study using the Pulsta valve (Tae Woong Medical Co, Gyeonggi-do, South Korea) for native RVOTs was reported; the diameter of the Pulsta valve ranges from 18 to 32 mm. Herein, we present a successful percutaneous bilateral branch PA valve implantation using two 32 mm Pulsta valves in a 59-year-old man who showed right heart failure with severe pulmonary regurgitation despite several open heart surgeries for tetralogy of Fallot. The main PA was measured to be 49 mm, and both the right and left PAs were measured to be 30 mm.

9. England pubmed.ncbi.nlm.nih.gov

Early results of Pulsta® transcatheter heart valve in patients with enlarged right ventricular outflow tract and severe pulmonary regurgitation due to transannular patch. [2023] The purpose of this study is to assess the feasibility, effectivity, and safety of a novel self-expandable valve system, Pulsta® transcatheter heart valve in patients with tetralogy of fallot and severe pulmonary regurgitation after transannular patch repair.