Last updated on February 2020

The Medtronic Harmony Transcatheter Pulmonary Valve Clinical Study

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: VALVULAR HEART DISEASE | Congenital Heart Disease | Tetrology of Fallot | Heart Valve Disease | Pulmonary insufficiency | RVOT Anomaly
  • Age: - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30%
  • Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
  • Subject is willing to consent to participate

Exclusion Criteria:

  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
  • RVOT anatomy or morphology that is unfavorable for device anchoring
  • Positive pregnancy test
  • Life expectancy of less than 1 year

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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