MASA Valve Early Feasibility Study
PECA Labs
Summary
The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.
Description
The MASA Valve is a bi-leaflet pulmonary valved conduit. The MASA Valve has an ePTFE conduit and ePTFE leaflets fixtured to the conduit with polypropylene suture. The device has a pad-printed design on the outer conduit surface indicating the valve position and direction of flow. . The MASA Valve is intended to be used to reconstruction the Right Ventricular Outflow Tract (RVOT) and provide a functional pulmonary valve. Once implanted, the MASA Valve provides a pathway for blood from the Right Ventricle (RV) to the Pulmonary Arteries (PAs), while the integrated valve helps to prevent backflow…
Eligibility
- Age range
- 0–22 years
- Sex
- All
- Healthy volunteers
- No
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 appropria…
Interventions
- DeviceSurgical Right Ventricular Outflow Tract Reconstruction
Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)
Locations (5)
- OSF Childrens Hospital of IllinoisPeoria, Illinois
- Boston Childrens HospitalBoston, Massachusetts
- Cincinnati Children's HospitalCincinnati, Ohio
- Childrens Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Childrens Medical Center DallasDallas, Texas