An interventional study of Surgical Right Ventricular Outflow Tract Reconstruction in Tetrology of Fallot, Pulmonary Stenosis and Truncus Arteriosus, sponsored by PECA Labs. Recruiting at 5 sites in United States. Open to participants aged 0 Years to 22 Years. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by PECA Labs · Not applicable, Interventional, and Device feasibility
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.
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:
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.
26 studies on the registry are indexed under Pulmonary Valve Stenosis; 5 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 12 interventional studies indexed under Pulmonary Valve Stenosis.
Browse Pulmonary Valve Stenosis studies →This is the only study on the registry with PECA Labs as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This is a single-arm study. All participants in this study will undergo implantation with MASA Valve.
Device: Surgical Right Ventricular Outflow Tract Reconstruction
Surgical replacement of the Pulmonary Valve or a previously implanted prosthetic with the investigational device (MASA Valve)
Freedom from device related death
Percentage of patients that have not died related to the device 1 year from implantation
Time frame: 1 year
Freedom from Explant
Percentage of patients that have not undergone device explant within 1 year from implantation
Time frame: 1 year
Freedom from Device-Related Reoperation
Percentage of patients that have not undergone re-operation related to the device within 1 year from implantation
Time frame: 1 year
Freedom from Device-Related Catheter Intervention
Percentage of patients that have not undergone device related catheter based intervention within 1 year from implantation
Time frame: 1 year
Freedom from Endocarditis
Percentage of patients that have not had endocarditis within 1 year from implantation
Time frame: 1 year
Freedom from Thrombus
Percentage of patients that have not had a serious thrombotic event related to the device within 1 year from implantation
Time frame: 1 year
Freedom from Major Hemorrhage
Percentage of patients that have not had a major bleeding episode related to the device within 1 year from implantation
Time frame: 1 year
Freedom from Moderate or Greater Pulmonary Regurgitation
Percentage of patients that show less than Moderate Pulmonary Regurgitation within 1 year from implantation on Echocardiographic assessment
Time frame: 1 year
Freedom from Pulmonary Gradient ≥36mmHg
Percentage of patients that have a Pulmonary Gradient \<= 36mmHg within 1 year from implantation on Echocardiographic assessment
Time frame: 1 year
Freedom from device valve failure
Percentage of patients that show do not show valve functional failure on Echocardiographic assessment
Time frame: 1 year
Plan to share: Undecided — Only anonymized data is intended to be shared with other clinicians.
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