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New treatment option for Tetrology of Fallot
Official title MASA Valve Early Feasibility Study
ClinicalTrials.gov ID: NCT05452720
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 22
You may be able to join if
- At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or...
- 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...
You likely can't join if
- 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...
- Patient has an active endocarditis
- Leukopenia, according to local laboratory evaluation of white blood cell count
See the full eligibility 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...
- 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...
- 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)
- Patient has an active endocarditis
- Leukopenia, according to local laboratory evaluation of white blood cell count
- Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
- Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
- Severe chest wall deformity, which would preclude placement of the PV conduit
- Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
- Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
- Patient has chronic inflammatory / autoimmune disease
- Need for emergency cardiac or vascular surgery or intervention
- Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
- Currently participating, or participated within the last 30 days, in an investigational drug or device study
- Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
- Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Illinois, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 22 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Illinois, United States; Boston, Massachusetts, United States; Cincinnati, Ohio, United States; Philadelphia, Pennsylvania, United States; Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.