Actively Recruiting
MASA Valve Early Feasibility Study
Led by PECA Labs · Updated on 2024-11-06
10
Participants Needed
5
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MASA Valve Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is younger than 22 years
- Has a right ventricular to pulmonary artery mean gradient greater than 35 mm Hg, moderate or severe pulmonary regurgitation (3+ or more), or a clinical need to replace their native or prosthetic pulmonary valve
- Patient is geographically stable and willing to return for 1 year follow-up visits
- Patient's legal guardian is willing to provide informed consent at the enrolling hospital
- Patient and legal representative, and treating physician agree to comply with all required post-procedure follow-up visits
You will not qualify if you...
- Patient has a prosthetic heart valve in any position other than the pulmonary valve
- Requires non-cardiac surgical procedures at the same time
- Has a previously implanted pacemaker, defibrillator, or mechanical heart valve
- Has an active bacterial or viral infection or is currently on antibiotic treatment
- Has active endocarditis
- Has leukopenia based on local lab tests
- Has acute or chronic anemia (may be transfused to qualify)
- Has thrombocytopenia with platelet count below 150,000/mm3 (may be transfused to qualify)
- Has severe chest wall deformity preventing placement of the pulmonary valve conduit
- Has known allergy to anticoagulants, antiplatelet drugs, or device materials
- Is immunocompromised due to autoimmune disease or immune therapy
- Has chronic inflammatory or autoimmune disease
- Needs emergency cardiac or vascular surgery or intervention
- Has major or progressive non-cardiac disease with life expectancy less than one year
- Currently or recently (within 30 days) participating in another investigational drug or device study
- Has alcohol or drug abuse history in the past 12 months
- Has medical, social, or psychosocial factors affecting safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
OSF Childrens Hospital of Illinois
Peoria, Illinois, United States, 61637
Actively Recruiting
2
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Childrens Medical Center Dallas
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Arush Kalra, MBBS, MS
CONTACT
D
Doug Bernstein, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here