MASA Valve Early Feasibility Study

Launched by PECA LABS · Jul 6, 2022

Keywords

ClinConnect Summary

The MASA Valve Early Feasibility Study is a research trial aimed at testing a new device called the MASA Valve in patients with certain heart conditions, such as Tetralogy of Fallot and Pulmonary Stenosis. The main goal of the study is to assess how safe this valve is and whether it can help patients who need surgery to improve blood flow from the heart to the lungs. The study is currently recruiting participants, including children and young adults up to 22 years old, who meet specific health criteria, such as having high blood pressure in the heart or severe valve problems.

If someone is eligible and decides to participate, they can expect to have the MASA Valve implanted and will need to return for follow-up visits over the next year to monitor their health and the device's performance. It's important for patients to have a legal guardian who can provide consent, and they should be willing to attend all required appointments. This trial is an important step toward understanding how this new valve could benefit young patients with serious heart conditions, potentially leading to more effective treatments in the future.

Gender

ALL

Eligibility 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