Evaluation of the MASA Valve for heart surgery in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MASA Valve Early Feasibility Study aims to assess the safety and potential benefits of the MASA Valve, a bi-leaflet pulmonary valved conduit, in children under 22 years old with specific congenital heart defects requiring Right Ventricular Outflow Tract Reconstruction. This multi-site interventional trial will follow a common protocol across various centers in the United States. The study seeks to gather early data to support future pivotal studies and regulatory submissions by evaluating the device's feasibility and effectiveness in providing a functional pulmonary valve.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
2. Age \< 22 years
3. Patient is geographically stable and willing to return for 1 year follow-up for the trial.
4. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
5. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.

Exclusion Criteria:

1. Patient is in need of or has presence of a prosthetic heart valve at any other position
2. Patient has a need for concomitant surgical procedures (non-cardiac)
3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
4. Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
5. Patient has an active endocarditis
6. Leukopenia, according to local laboratory evaluation of white blood cell count
7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
8. Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
9. Severe chest wall deformity, which would preclude placement of the PV conduit
10. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
11. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
12. Patient has chronic inflammatory / autoimmune disease
13. Need for emergency cardiac or vascular surgery or intervention
14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
15. Currently participating, or participated within the last 30 days, in an investigational drug or device study
16. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
17. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance

Where it's running

• OSF Childrens Hospital of Illinois
  Peoria, Illinois, United States Recruiting
• Boston Childrens Hospital
  Boston, Massachusetts, United States Recruiting
• Cincinnati Children's Hospital
  Cincinnati, Ohio, United States Recruiting
• Childrens Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Childrens Medical Center Dallas
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: David Morales, MD — Cinncinnati Childrens Hospital
• Study coordinator: Arush Kalra, MBBS, MS
• Email: arush@pecalabs.com
• Phone: 4123300746

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.