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NCT ID: NCT05452720 Recruiting - Clinical trials for Transposition of Great Vessels

MASA Valve Early Feasibility Study

MVEFS
Start date: May 18, 2023
Phase: N/A
Study type: Interventional

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.