The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:12/23/2018
Start Date:January 2017
End Date:December 2024
Contact:Stephanie Salisbury
Email:stephanie.salisbury@medtronic.com
Phone:+16129797251

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™
TPV system.


Inclusion Criteria:

- 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

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

- Positive pregnancy test

- Life expectancy of less than 1 year
We found this trial at
10
sites
Seattle Children's Hospital
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Thomas Jones, MD
Phone: 206-987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: John P Cheatham, MD, MSCAI
Phone: 614-722-6124
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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Children's Hospital of Philadelphia
South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Matthew Gillespie, MD
Phone: 215-590-1790
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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from
Philadelphia, PA
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Texas Children's Hospital
6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Principal Investigator: Henri Justino, MD
Phone: 832-824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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Houston, TX
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Ronald Regan UCLA Medical Center
Los Angeles, California 90095
Principal Investigator: Daniel Levi, MD
Phone: 310-267-7667
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from
Los Angeles, CA
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Yale University
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Jeremy Asnes, MD
Phone: 203-785-2022
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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mi
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New Haven, CT
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Stanford University Medical Center
Palo Alto, California 94304
Principal Investigator: Doff McElhinney, MD
Phone: 650-736-9364
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from
Palo Alto, CA
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The Mayo Clinic
Rochester, Minnesota 55905
Principal Investigator: Allison Cabalka, MD
Phone: 507-255-5123
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from
Rochester, MN
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Primary Children's Hospital
Salt Lake City, Utah 84143
Principal Investigator: Robert Gray, MD
Phone: 801-662-1000
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from
Salt Lake City, UT
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The Hospital for Sick Children (SickKids)
555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Lee Benson, MD
Phone: 416-813-6141
?
mi
from
Toronto,
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