Medtronic Harmony TPV Post-Approval Study

What is the Purpose of this Study?

The purpose of this study is to evaluate the functionality of transcatheter implantation (a minimally invasive procedure) of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV). Significant pulmonary regurgitation (abnormal reversal of blood flow in the heart) often occurs in people who have previously treated congenital heart disease with a missing or malformed pulmonary valve and do not have a tube connecting the right pumping chamber (ventricle) and the lung artery (pulmonary artery). These patients require an operation to treat the pulmonary valve and improve the regurgitation caused by the condition. The Medtronic Harmony Transcatheter Pulmonary Valve is different than having open heart surgery because a small needle puncture is made into the groin or neck, instead of cutting the chest open. The doctor will then insert the new heart valve through a long, flexible tube (catheter) and guide it to the heart through a vein and place it into the area between the heart and lungs. The Harmony TPV system is approved by the U.S. Food and Drug Administration (FDA) for patients who have severe pulmonary regurgitation and have a native or surgically repaired right ventricular outflow tract (RVOT).


Eligibility

  • * 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
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Harmony Post-Approval Study

Study Details
Disease Type/Condition

Other

Principal Investigator

Zahn, Evan

Age Group

Both

Phase

N/A

IRB Number

STUDY00001755

ClinicalTrials.gov ID

NCT02979587

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Zahn, Evan

Age Group

Both

Phase

N/A

IRB Number

MDT20057CON003

ClinicalTrials.gov ID

NCT02979587

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org