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.
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.
Age < 22 years
Patient is geographically stable and willing to return for 1 year follow-up for the trial.
Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
Patient is in need of or has presence of a prosthetic heart valve at any other position
Patient has a need for concomitant surgical procedures (non-cardiac)
Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
Single group
Surgical Right Ventricular Outflow Tract Reconstruction
DeviceSurgical 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
Freedom from Explant
Percentage of patients that have not undergone device explant within 1 year from implantation
Freedom from Device-Related Reoperation
Percentage of patients that have not undergone re-operation related to the device within 1 year from implantation
Freedom from Device-Related Catheter Intervention
Percentage of patients that have not undergone device related catheter based intervention within 1 year from implantation
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
Freedom from Pulmonary Gradient ≥36mmHg
Percentage of patients that have a Pulmonary Gradient \<= 36mmHg within 1 year from implantation on Echocardiographic assessment
Freedom from device valve failure
Percentage of patients that show do not show valve functional failure on Echocardiographic assessment
