Harmony TPV Clinical Study

Principal Investigator: Robert Gray
Keywords: Cardiac , Transcatheter pulmonary valve , Congenital Heart Disease Department: Pediatric Cardiology
IRB Number: 00097096 Co Investigator: Mary Martin
Specialty: Cardiology, Pediatric Cardiology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Judy Carle
judy.carle@hsc.utah.edu
801-585-9375

Brief Summary

The primary objective of this study is to demonstrate the safety and effectiveness of the Harmony TPV system as measured by freedom from procedure or device-related mortality at 30 days and percentage of subjects with acceptable hemodynamic function at 6 months. 

Inclusion Criteria

Inclusion Criteria:

Participant has pulmonary regurgitation as per one or more of the following criteria:

  • Severe pulmonary regurgitation as measured by Doppler echocardiography, or
  • 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:

  • Participant is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the investigator, or
  • Right ventricular end diastolic volume index (RVEDVi) ≥ 150 ml/m2, or
  • Participant has RVEDV: LVEDV Ratio ≥ 2.0

Participant is willing to consent to participate in the study and will commit to completion of all followup
requirements

Exclusion Criteria

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 Harmony™ TPV implant
  • Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female particpants of child bearing potential
  • Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a 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