A single arm, prospective, non-randomized, multi-center clinical investigation of the SJMTM MastersSeries 15mm Rotatable Mechanical Heart Valve (15mm MHV Clinical Study)
A study for children using a new St. Jude's mechanical heart valve.
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
Additional Study Information: 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
Do You Qualify?
Does your child require a mitral valve replacement? Yes No
Is your child older than 5 years of age? Yes No
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For more information, please contact:
Emile Bacha
eb2709@columbia.edu
212-305-2688