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

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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
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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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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Philadelphia, PA
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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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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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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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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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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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Salt Lake City, UT
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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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The Hospital for Sick Children (SickKids)
555 University Avenue
Toronto, Ontario M5G 1X8
Principal Investigator: Lee Benson, MD
Phone: 416-813-6141
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mi
from
Toronto,
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