Pulmonary Valve Replacement for Congenital Heart Disease

Not yet recruiting at 9 trial locations

Overseen By Paul Mehoudar, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Autus Valve Technologies, Inc.

Must not be taking: Anticoagulants, Antiplatelet, Immunosuppressants, Immunostimulants

Disqualifiers: Pulmonary hypertension, Renal insufficiency, Anemia, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

Prospective, single-arm, multi-center, continued access study of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implantation, at hospital discharge, 30 days, 6 months, and annually through 10 years.

The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject.

Are You a Good Fit for This Trial?

Inclusion Criteria

Subject and parent/legal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits

Subject has at least one of the following echocardiographic findings: Severe pulmonary stenosis (RV to PA peak instantaneous gradient ≥60 mmHg), Moderate or greater pulmonary regurgitation, Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation

I am between 18 months and 16 years old.

Exclusion Criteria

I do not accept blood transfusions.

I have a serious narrowing of the arteries in my lungs.

Subject has a known history of thrombocytopenia (defined as platelet count <50 x 103/µL)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Implant Evaluation

Subjects are evaluated prior to the Autus Valve implant procedure

1 week

1 visit (in-person)

Treatment

Autus Valve implantation and immediate post-implantation evaluation

1 week

1 visit (in-person)

Post-Implant Monitoring

Subjects are monitored at hospital discharge, 30 days, and 6 months post-implantation

6 months

3 visits (in-person)

Long-term Follow-up

Annual evaluations through 10 years post-valve implantation

10 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Autus Valve

How Is the Trial Designed?

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+