Evaluation of the MASA Valve for heart surgery in children
MASA Valve Early Feasibility Study
This study is testing a new heart valve designed for children with certain heart defects to see if it is safe and helps improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 0 Years to 22 Years |
| Sex | All |
| Sponsor | PECA Labs Industry-sponsored |
| Locations | 5 sites (Peoria, Illinois and 4 other locations) |
| Trial ID | NCT05452720 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children under 22 years old with conditions such as Tetralogy of Fallot, Pulmonary Stenosis, or other specified congenital heart malformations requiring RVOT reconstruction.
Not a fit: Patients who have a prosthetic heart valve in any other position or require non-cardiac surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new surgical option for children with congenital heart defects, improving their quality of life and long-term outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in the use of valved conduits for congenital heart defects, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Peoria, Illinois and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.