The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Trial Purpose and Description

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

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.


Eligibility Criteria

Criteria

Inclusion Criteria:

  • Subject has pulmonary regurgitation
  • Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve

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

Medtronic, Inc

Dates: 03/17/2017 - 12/31/2018

Last Updated: 03/19/2017

Study HIC#: 2000020113

Get Involved

For more information about this study, contact:
Amanda Catucci
203-785-6947
amanda.catucci@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

Trial Image

Investigators

Jeremy David Asnes

Principal Investigator

Sub-Investigators