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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
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
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.
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.Check my eligibility
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.See study design
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 belowSelect...
I have severe issues with my heart valves affecting lung blood flow.
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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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Valve Implantation Primary Effectiveness Endpoint
Valve Implantation Primary Safety Endpoint
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 moreOther outcome measures
Other Effectiveness Outcome - Left Ventricular Measures
Other Effectiveness Outcome - Modified Ross Functional Classification
Other Effectiveness Outcome - PedsQL - Cardiac Module
+18 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I have kidney problems.My pulmonary artery is long enough for the device implant.You are allergic to medications that prevent blood from clotting or reduce platelet activity.You have low levels of white blood cells.I have anemia.I have severe issues with my heart valves affecting lung blood flow.I have a narrowing in the arteries of my lungs.My heart's right ventricular outflow tract is natural or has been repaired.I have high blood pressure in the arteries of my lungs.I need surgery that is not related to my heart.I have or will need a prosthetic valve replacement soon.I have a low platelet count.I have a heart condition where the pulmonary valve is blocked and there are abnormal blood vessels.I need emergency heart or blood vessel surgery.I have or had an infection in the heart's inner lining.I refuse to receive blood transfusions.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.I, along with my guardian and doctor, agree to follow all study requirements.I have an autoimmune disease or take drugs that affect my immune system.I am between 18 months and 16 years old.My doctors recommend I get a heart valve surgery.I am currently taking antibiotics for an infection.I need a heart valve replacement, but not for the pulmonary valve.
Research Study Groups:
This trial has the following groups:- Group 1: Autus Valve Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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