Ensayos clínicos

Inclusion Criteria:

• Subject has pulmonary regurgitation as per one or more of the following criteria:
  • Severe pulmonary regurgitation as measured by continuous-wave Doppler echocardiography;
  • Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging.
• Clinical indication for surgical placement of a RV-PA conduit or prosthetic pulmonary valve per one or more of the following criteria:
  • Subject is symptomatic secondary to pulmonary insufficiency (e.g., exercise intolerance, fluid overload) as classified by the investigator;
  • Subject has right ventricular end diastolic volume index (RVEDVi) ≥ 150 ml/m2;
  • Subject has RVEDV: LVEDV Ratio ≥ 2.0.
• Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements.

Exclusion Criteria

• Anatomy unable to accommodate a 25 Fr delivery system.
• Obstruction of the central veins.
• Clinical or biological signs of infection including active endocarditis.
• Planned concomitant procedure at time of implant.
• Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential.
• Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-PA conduit implant.
• A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year.
• Planned implantation of the Harmony™ TPV in the left heart.
• RVOT anatomy or morphology that is unfavorable for device anchoring.
• Known allergy to aspirin, heparin, or nickel.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Pre-existing prosthetic heart valve or prosthetic ring in any position.