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Prosthetic Valve

Pulmonary Valve Replacement for Congenital Heart Disease

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
Age 18 months to 16 years
Subject's pulmonary artery length is adequate for implantation of the study device
Must not have
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up12 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will evaluate the safety and effectiveness of the Autus Valve in children aged 2-10 years old who require surgical pulmonary valve replacement. The Autus Valve can be expanded to match the subject's body size before implant, and can also be expanded post-implant via transcatheter balloon dilation to accommodate growth. Follow-up will continue for at least 5 years after implant.

Eligible Conditions
  • Congenital Heart Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You must be between 18 months and 16 years old.
The size of the subject's pulmonary artery is suitable for the study device to be implanted.
You have a natural or fixed issue with the pathway of blood leaving the right side of your heart.
Your doctors have suggested that you should have surgery to replace your pulmonary valve.
You have certain heart problems as seen on an echocardiogram, like severe pulmonary stenosis or moderate to severe pulmonary regurgitation.
Your body size is suitable for the device to be placed, and it should fit a range from 12.7 to 22 mm in diameter.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-implant Valve Expansion Primary Effectiveness Endpoint
Tissue Expansion
Valve Implantation Primary Effectiveness Endpoint
+1 more
Secondary outcome measures
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

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

Find a Location

Who is running the clinical trial?

Autus Valve Technologies, Inc.Lead Sponsor
Steven Colan, MD.Principal InvestigatorBonston Children's Hospital, Echo Core Lab
Sophie-Charlotte Hofferberth, MDStudy DirectorAutus Valve Technologies, Inc.

Media Library

Autus Size-Adjustable Valve (Prosthetic Valve) Clinical Trial Eligibility Overview. Trial Name: NCT05006404 — N/A
Congenital Heart Disease Research Study Groups: Autus Valve Arm
Congenital Heart Disease Clinical Trial 2023: Autus Size-Adjustable Valve Highlights & Side Effects. Trial Name: NCT05006404 — N/A
Autus Size-Adjustable Valve (Prosthetic Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05006404 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the restrictions around age for this particular clinical trial?

"This trial is seeking young participants who are between 18 months and 11 years old."

Answered by AI

Who meets the qualifications for this clinical trial?

"This clinical trial is enrolling 15 people who have heart diseases and are between the ages of 18 months and 11 years old. The following inclusion criteria must be met in order to be considered for enrollment:-Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter)-Age 2 to 10 years old (± 6 months)-Male or female-Subject has a native or repaired right ventricular outflow tract-Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon)-Se"

Answered by AI

Are people still able to apply for this experiment?

"That is correct. As shown on clinicaltrials.gov, this clinical trial is looking for 15 patients from 3 locations. The trial was first posted on December 6th, 2021 and was last edited on September 13th, 2022."

Answered by AI
~5 spots leftby Dec 2024