This study is in progress, not accepting new patients

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

a study on Congenital Heart Defects Tetralogy of Fallot RVOT Anomaly Pulmonary Regurgitation

Summary

Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Details

The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States. The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

Keywords

Congenital Heart Disease Tetrology of Fallot RVOT Anomaly Pulmonary Regurgitation Heart Diseases Heart Defects, Congenital Pulmonary Valve Insufficiency Tetralogy of Fallot Harmony TPV System

Eligibility

You can join if…

  • 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

You CAN'T join if...

  • 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

Locations

  • Ronald Regan UCLA Medical Center
    Los Angeles California 90095 United States
  • Stanford University Medical Center
    Palo Alto California 94304 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Heart Valves
ID
NCT02979587
Study Type
Interventional
Participants
At least 86 people participating
Last Updated