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. ^{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}

Research Team

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.

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

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.

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 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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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

Midterm evaluation of biological prosthetic valves in the pulmonary position of grown-up patients. [2012]

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]

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]

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

Extending the limits of the Ross procedure. [2019]

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

Long-term outcomes of pulmonary valve replacement in patients with repaired tetralogy of Fallot. [2021]

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]

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]