The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness of the Harmony TPV system.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Allison Cabalka, M.D.

Open for enrollment

Contact information:

Cheryl Wasson R.N.

(507)255-0876

Wasson.Cheryl@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available