Pulmonary Valve Replacement for Congenital Heart Disease

Recruiting at 11 trial locations

Overseen By Paul Mehoudar, M.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Autus Valve Technologies, Inc.

Must not be taking: Antibiotics, Anticoagulants, Antiplatelets, Immunosuppressants

Disqualifiers: Pulmonary hypertension, Renal insufficiency, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: Immediate post-implant to hospital discharge

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special valve designed for children needing surgery to repair their heart's pulmonary valve. The goal is to determine if the Autus Size-Adjustable Valve, which adjusts as a child grows, is safe and effective. It suits children whose doctors recommend this surgery, particularly those with severe heart issues like impaired blood flow or leaky valves. Researchers will monitor participants closely for up to 10 years to track progress and any changes in heart condition. As an unphased trial, this study provides a unique opportunity for children to access innovative treatment that could enhance their heart health as they grow.

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 prior data suggests that the Autus Size-Adjustable Valve is safe for pediatric patients?

Research has shown that the Autus Size-Adjustable Valve is proving to be safe. In a previous study, the valve functioned well for a year without any device-related complications, indicating its safety for patients. Designed to grow with the child, the valve offers a new solution for children needing a pulmonary valve replacement. The safety results are promising, but ongoing studies will continue to assess its long-term effectiveness and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Autus Size-Adjustable Valve is unique because it offers customization in pulmonary valve replacement for congenital heart disease. Unlike traditional fixed-size valves, the Autus Valve can be adjusted to better fit the patient's anatomy, potentially reducing complications and the need for future surgeries. Researchers are excited about this innovation as it promises to enhance patient outcomes by improving the valve's durability and performance over time.

What evidence suggests that the Autus Valve is effective for pulmonary valve replacement in congenital heart disease?

Research has shown that the Autus Size-Adjustable Valve could benefit children with congenital heart disease who need a new pulmonary valve. In studies, children with the Autus Valve maintained good valve function and experienced no valve-related issues after one year. A key feature of this valve is its ability to grow with the child, eliminating the need for additional surgeries. This flexibility reduces the likelihood of future procedures, offering a significant advantage for growing children. Overall, early findings suggest the Autus Valve could serve as an effective treatment option. ^{1 2 3 4 6}

Who Is on the Research Team?

Sophie-Charlotte Hofferberth, MD

Principal Investigator

Autus Valve Technologies, Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Autus Size-Adjustable 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Autus Valve Technologies, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

The Ross procedure, involving the use of the autologous pulmonary valve for aortic valve replacement, was performed on 35 patients, including infants and those with complex heart conditions, showing promising results with no late deaths or reinterventions during a median follow-up of 9 months.

The autologous pulmonary valve demonstrated excellent function post-surgery, with only 2.8% of patients experiencing moderate insufficiency, indicating its effectiveness and safety as a replacement option across various age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extending the limits of the Ross procedure. Reddy, VM., Rajasinghe, HA., McElhinney, DB., et al.[2019]

Percutaneous pulmonary valve implantation (PPVI) using the Pulsta valve has been successfully performed in a 59-year-old patient with severe pulmonary regurgitation, demonstrating its potential as a viable alternative to traditional surgical methods.

The use of two 32 mm Pulsta valves in this case resulted in a reduction of right ventricular volume and clinical improvement, suggesting that this approach may benefit patients with complex RVOT lesions who have previously undergone multiple surgeries.

NCBI (Pubmed)

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. Kim, JY., Kim, SH., Jang, SI.[2022]

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.

NCBI (Pubmed)

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. Reddy, VM., McElhinney, DB., Phoon, CK., et al.[2016]

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.

NCBI (Pubmed)

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. Houeijeh, A., Sudre, A., Juthier, F., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midterm evaluation of biological prosthetic valves in the pulmonary position of grown-up patients. Vohra, HA., Whistance, RN., Baliulis, G., et al.[2012]

In a study of 190 patients who underwent pulmonary valve replacement (PVR) after repairing tetralogy of Fallot (TOF), the long-term outcomes were positive, with a 15-year transplantation-free survival rate of 95% and freedom from adverse clinical events (ACEs) at 90%.

Factors such as older age at PVR, presence of tachyarrhythmias, and larger heart volumes identified through preoperative MRI were associated with higher risks of adverse clinical events, suggesting that earlier intervention may improve long-term survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of pulmonary valve replacement in patients with repaired tetralogy of Fallot. Lee, C., Choi, ES., Lee, CH.[2021]

Transcatheter valves (TCVs) provide equivalent performance to surgical pulmonary valve replacements (PVRs) and significantly extend the durability of the valves, effectively doubling the time before needing replacement compared to conventional valves.

The study found that the median interval between procedures for PVR patients has decreased to 2.6 years, with a significant number of patients (42%) undergoing three or more procedures by the age of 30, highlighting the ongoing need for valve replacements in this population.

NCBI (Pubmed)

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. Boethig, D., Avsar, M., Bauer, UMM., et al.[2022]

In a study of 76 patients undergoing pulmonary autograft surgery, mid-term results showed that geometric discrepancies of up to 3 mm between the recipient annulus and the pulmonary autograft did not significantly affect valve regurgitation or pressure gradients.

The findings suggest that the pulmonary autograft procedure can be simplified without compromising outcomes, indicating its potential as a reliable aortic valve substitute even with variations in valve size and shape.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Ross operation: do native aortic, native pulmonary, and homograft pulmonary valve size and form differences influence results? Botha, CA., Rein, JG., Böhm, JO., et al.[2004]

The Pulsta® transcatheter heart valve was successfully implanted in 10 patients with severe pulmonary regurgitation after tetralogy of Fallot repair, demonstrating feasibility and safety without severe complications during the procedure.

At the 6-month follow-up, valve function was excellent in 6 out of 10 patients, indicating that the Pulsta® valve is effective in treating this condition, with only minor regurgitation observed in the remaining patients.

NCBI (Pubmed)

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. Odemis, E., Yenidogan, I., Kizilkaya, MH.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05006404

Study Details | NCT05006404 | Autus Valve 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 ...

2. jtcvs.org jtcvs.org/article/S0022-5223(25)00642-7/fulltext

Novel size-adjustable pulmonary valve US early feasibility ... Outcome and performance of bioprosthetic pulmonary valve replacement in patients with congenital heart disease. J Thorac Cardiovasc Surg ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022522325006427

Novel Size-Adjustable Pulmonary Valve U.S. Early ... One-year results of the novel Autus Size-Adjustable Valve EFS demonstrated intact valve function and no device-related adverse events. The ...

4. structuralheartjournal.org structuralheartjournal.org/article/S2474-8706(25)00132-0/fulltext

72345 | Novel Size-Adjustable Pulmonary Valve U.S. Early ... In this feasibility study evaluating the novel Autus Size-Adjustable Valve, one-year results demonstrated intact valve function and no device-related adverse ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05006404/autus-valve-pivotal-study

Autus Valve Pivotal Study | Clinical Research Trial Listing 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40752778/

Novel size-adjustable pulmonary valve US early feasibility ... One-year results of the novel ASAV Early Feasibility Study demonstrated intact valve function and no device-related adverse events.