Actively Recruiting
MASA Valve Early Feasibility Study for Right Ventricular Outflow Tract Reconstruction in Patients Under 22 Years with Congenital Heart Malformations
Led by PECA Labs · Updated on 2024-11-06
10
Participants Needed
5
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and potential benefits of the MASA Valve in children and young adults under 22 years old who require reconstruction of the Right Ventricular Outflow Tract (RVOT) due to congenital heart conditions such as Pulmonary Stenosis, Tetralogy of Fallot, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, or those undergoing the Ross Procedure. This early feasibility study gathers initial data to support future studies or regulatory approval. Participants will receive the MASA Valve, a bi-leaflet pulmonary valved conduit made of ePTFE material with integrated leaflets designed to restore blood flow from the right ventricle to the pulmonary arteries while preventing backflow. The valve is surgically implanted to replace or reconstruct the RVOT, including replacement of dysfunctional pulmonary valves or conduits. This is a single-arm study where all participants undergo implantation with the investigational device. During the study, participants will be monitored over one year with follow-up visits to assess safety and device performance, including freedom from device-related death, explant, reoperation, catheter interventions, endocarditis, thrombus, and major hemorrhage. Researchers will also evaluate valve function, pulmonary regurgitation, pulmonary gradient, and valve failure. Participants must be willing to return for follow-up visits and comply with study procedures throughout the trial period.
CONDITIONS
Brief Title
MASA Valve Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Right Ventricular to Pulmonary Artery mean gradient greater than 35 mm Hg, moderate or severe pulmonary regurgitation, or clinical indication for pulmonary valve replacement
- Age less than 22 years
- Geographically stable and willing to return for one year follow-up
- Legal guardian willing to provide informed consent at enrollment site
- Agreement by patient, guardian, and physician to comply with all required follow-up visits
You will not qualify if you...
- Presence of prosthetic heart valve in any position other than pulmonary valve
- Need for non-cardiac concomitant surgical procedures
- Previously implanted pacemaker or mechanical valves
- Active bacterial or viral infection or current antibiotic therapy (temporary illness allowed after 4 weeks of stopping antibiotics)
- Active endocarditis
- Leukopenia based on local lab evaluation
- Acute or chronic anemia (patients may be transfused to meet criteria)
- Thrombocytopenia with platelet count less than 150,000/mm3 (patients may be transfused to meet criteria)
- Severe chest wall deformity preventing pulmonary valve conduit placement
- Known hypersensitivity to anticoagulants, antiplatelet drugs, or device materials
- Immunocompromised status including autoimmune disease or use of immunosuppressants
- Chronic inflammatory or autoimmune disease
- Need for emergency cardiac or vascular surgery or intervention
- Major or progressive non-cardiac disease with life expectancy under one year
- Participation in another investigational drug or device study within last 30 days
- Alcohol or drug abuse within last 12 months
- Medical, social, or psychosocial factors impacting safety or compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until discharge
Participants undergo surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational MASA Valve device.
1 surgical procedure with hospital stay and immediate post-operative monitoring
Duration - Up to 1 year
Participants are monitored with follow-up visits to assess device performance and safety after surgery.
Approximately 6 follow-up visits over 12 months
Trial Site Locations
Total: 5 locations
1
OSF Childrens Hospital of Illinois
Peoria, Illinois, United States, 61637
Actively Recruiting
2
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Childrens Medical Center Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Arush Kalra, MBBS, MS
D
Doug Bernstein, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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