A single arm, prospective, non-randomized, multi-center clinical investigation of the SJMTM MastersSeries 15mm Rotatable Mechanical Heart Valve (15mm MHV Clinical Study)
Sponsor: |
St. Jude Medical |
Enrolling: |
Male and Female Patients |
IRB Number: |
AAAL9202 |
U.S. Govt. ID: |
NCT02097420 |
Contact: |
Emile Bacha: 212-305-2688 / eb2709@columbia.edu |
The purpose of this study is to gather more information about how effective the St. Jude Medical (SJM) TMMasters Series 15mm Rotatable Mechanical Heart Valve (15mm valve) is at treating a child's condition, as well as collecting information about the safety of the valve. The childs surgeon will have determined that child will likely require the 15mm valve.
This study is closed
Investigator
Emile Bacha, MD
Does your child require a mitral valve replacement? |
Yes |
No |
Is your child older than 5 years of age? |
Yes |
No |