MASA Valve Early Feasibility Study (NCT05452720) | Clinical Trial Compass
RecruitingNot Applicable
MASA Valve Early Feasibility Study
United States10 participantsStarted 2023-05-18
Plain-language 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.
Who can participate
Age range0 Years – 22 Years
SexALL
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Inclusion criteria
✓. 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.
✓. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
Exclusion criteria
✕. 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)