Page 5 - Journal of Structural Heart Disease Volume 4, Issue 1

NOW ENROLLING:
HarmonyTM TranscatheterPulmonary Valve (TPV) Clinical Study
WHAT IS THE MEDTRONIC HARMONY TPV CLINICAL STUDY?
The study is a multi-center prospective, non-randomized, interventional pre-market study in the United States. The purpose of the study is to evaluate the safety and effectiveness of the Harmony TPV system in patients who have congenital heart disease and are clinically indicated for pulmonary valve replacement. The trial will involve up to 40 subjects implanted at 10 study centers.
WHO CAN PARTICIPATE?
Patients who have pulmonary regurgitation:
· Severe pulmonary regurgitation by echocardiography, or
· Pulmonary regurgitant fraction ≥ 30% by cardiac magnetic resonance imaging
Patients who have a clinical indication for surgical placement of a RV-PA conduit or prosthetic pulmonary valve:
· Subject is symptomatic secondary to pulmonary insufficiency (e.g., exercise intolerance, fluid overload), or
· Right ventricular end diastolic volume index ≥ 150 mL/m2, or
· Subject has RVEDV:LVEDV Ratio ≥ 2.0
HOW CAN I LEARN MORE ABOUT THE HARMONY TPV CLINICAL STUDY?
For additional information about the program, please contact Medtronic at:
RS.HarmonyTPVClinicalStudy@medtronic.com
CAUTION: Investigational Device. Limited by Federal Law (USA) to Investigational Use.
medtronic.com
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Tel: (763) 514-4000
Fax: (763) 514-4879 Toll-free: (800) 328-2518
LifeLine
CardioVascular Technical Support Tel: (877)526-7890
Tel: (763) 526-7890
Fax: (763) 526-7888 rs.cstechsupport@medtronic.com
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UC201711884 EN 04/2017