Status: Recruiting
MASA Valve Early Feasibility Study
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.
Participants needed: 10
Trial details
Age: 0-22Biological sex: AllType: InterventionalSponsor: PECA LabsUpdated: Nov 6, 2024Locations: 5
Eligibility criteria
At least one of the following: Right Ventricular to Pulmonary Artery mean gradie... [+4]
Patient is in need of or has presence of a prosthetic heart valve at any other p... [+16]