Last updated on November 2019

The Medtronic Harmony Transcatheter Pulmonary Valve Clinical Study


Brief description of study

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

Detailed Study Description

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 device. The number of subjects implanted will not exceed 45 subjects in the United States and Canada.

Clinical Study Identifier: NCT02979587

Find a site near you

Start Over