NCT05452720

MASA Valve Early Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: PECA Labs · Industry
• Sex: All
• Age: 0 Years – 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 into the RV. The MASA Valve Indications for Use are: The MASA Valve pulmonary valved conduit is indicated for correction or reconstruction of the right ventricular outflow tract (RVOT) in patients aged less than 22 years with any of the following congenital cardiac malformations: * Pulmonary Stenosis * Tetralogy of Fallot * Truncus Arteriosus * Transposition of Great Vessels * Pulmonary Atresia In addition, the MASA Valve is indicated for the replacement of previously implanted, but dysfunctional, pulmonary valves, valved conduits or conduits, as well as for use in the Ross Procedure when the native RVOT is being used to reconstruct the Aorta. Treatments currently available for the above-stated conditions include biologic-tissue-based valved conduits (Homografts and Contegra Glutaraldehyde-fixed Bovine Jugular Vein), Intra-operatively constructed valved conduits made from off-the-shelf vascular grafts and cardiovascular membranes, and non-valved cardiovascular conduits. Based on existing evidence it is believed the potential benefits of MASA Valve outweigh the potential risks.

Conditions

• Tetrology of Fallot
• Pulmonary Stenosis
• Truncus Arteriosus
• Transposition of Great Vessels
• Pulmonary Atresia
• Ross Procedure

Interventions

Type	Name	Description
DEVICE	Surgical Right Ventricular Outflow Tract Reconstruction	Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)

Timeline

• Start date: 2023-05-18
• Primary completion: 2025-04-01
• Completion: 2028-04-01
• First posted: 2022-07-11
• Last updated: 2024-11-06

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study