What is the mechanism of action of this treatment?

The most common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and valve replacements. The Autus Size-Adjustable Valve, which can be expanded pre-implant to match the patient's body size and post-implant via transcatheter balloon dilation, exemplifies a modern approach to valve replacement. This size adjustability and expandability are crucial for pediatric patients, as they accommodate growth and reduce the need for multiple surgeries. These mechanisms ensure that the valve can grow with the child, improving long-term outcomes and quality of life by minimizing the frequency of invasive procedures.

What side effects are associated with this type of intervention?

Common treatments for Congenital Heart Disease, such as surgical pulmonary valve replacement and transcatheter interventions like the Autus Size-Adjustable Valve, can have several side effects. These may include bleeding, infection, arrhythmias, and valve dysfunction or failure. Specific to transcatheter balloon dilation, potential complications include vascular injury, thromboembolism, and issues related to the expansion mechanism, such as incomplete expansion or damage to surrounding tissues. Long-term follow-up is essential to monitor for these and other potential adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for Congenital Heart Disease, including devices and procedures that allow for size adjustability and expandability. One notable example is the Melody Transcatheter Pulmonary Valve, which can be expanded via balloon dilation to accommodate growth in pediatric patients. This approach is similar to the Autus Size-Adjustable Valve, which is designed to be expanded pre-implant to match the patient's body size and can be further expanded post-implant via transcatheter balloon dilation. These innovations aim to reduce the need for multiple surgeries as the patient grows, improving long-term outcomes and quality of life.

What other types of research exist?

Promising alternatives to the Autus Size-Adjustable Valve for CHD patients include: 1) The Melody Transcatheter Pulmonary Valve, which allows for minimally invasive implantation and can be expanded to accommodate growth. 2) The Edwards SAPIEN XT and SAPIEN 3 valves, known for their durability and ability to be expanded via balloon dilation. 3) The Harmony Transcatheter Pulmonary Valve, designed for patients with a native or surgically repaired right ventricular outflow tract, offering a minimally invasive option with expandable features.

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Prosthetic Valve

Pulmonary Valve Replacement for Congenital Heart Disease

N/A

Recruiting

Led By Steven Colan, MD.

Research Sponsored by Autus Valve Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has at least one of the following echocardiographic findings: Severe pulmonary stenosis, Moderate or greater pulmonary regurgitation, Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation

Subject has a native or repaired right ventricular outflow tract

Must not have

Subject has renal insufficiency

Subject has acute or chronic anemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months and annually through 10 years post-valve implantation. subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications from surgery, reactions to the device material, blood clot formation, bleeding due to anticoagulants used during procedure, infection risks, or issues related to heart function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have severe issues with my heart valves affecting lung blood flow.

Select...

My heart's right ventricular outflow tract is natural or has been repaired.

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I am between 18 months and 16 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have kidney problems.

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I have anemia.

Select...

I have a narrowing in the arteries of my lungs.

Select...

I have high blood pressure in the arteries of my lungs.

Select...

I need surgery that is not related to my heart.

Select...

I have or will need a prosthetic valve replacement soon.

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I have a low platelet count.

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I have a heart condition where the pulmonary valve is blocked and there are abnormal blood vessels.

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I need emergency heart or blood vessel surgery.

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I have or had an infection in the heart's inner lining.

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I refuse to receive blood transfusions.

Select...

I have an autoimmune disease or take drugs that affect my immune system.

Select...

I am currently taking antibiotics for an infection.

Select...

I need a heart valve replacement, but not for the pulmonary valve.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months and annually through 10 years post-valve implantation. subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months and annually through 10 years post-valve implantation. subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months and annually through 10 years post-valve implantation. subjects that undergo post-implant valve expansion will be evaluated pre-valve expansion, and at 6 and 12 months post-valve expansion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Valve Implantation Primary Effectiveness Endpoint

Valve Implantation Primary Safety Endpoint

Secondary study objectives

Secondary Effectiveness Echo-Related Endpoint - Freedom from Moderate or Greater Pulmonary Regurgitation

Secondary Effectiveness Echo-Related Endpoint - Left Ventricular Measures

Secondary Effectiveness Echo-Related Endpoint - Paravalvular Leak

+21 more

Other study objectives

Other Effectiveness Outcome - Left Ventricular Measures

Other Effectiveness Outcome - Modified Ross Functional Classification

Other Effectiveness Outcome - PedsQL - Cardiac Module

+18 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Autus Valve ArmExperimental Treatment1 Intervention

Pulmonary Valve Replacement Surgery with the Autus Valve

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Congenital Heart Disease (CHD) include surgical interventions, catheter-based procedures, and valve replacements. The Autus Size-Adjustable Valve, which can be expanded pre-implant to match the patient's body size and post-implant via transcatheter balloon dilation, exemplifies a modern approach to valve replacement. This size adjustability and expandability are crucial for pediatric patients, as they accommodate growth and reduce the need for multiple surgeries. These mechanisms ensure that the valve can grow with the child, improving long-term outcomes and quality of life by minimizing the frequency of invasive procedures.

Hemodynamic considerations in preterm infants born at less than 25 weeks gestation.