Melody PB1016 Surveillance Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:12/27/2018
Start Date:November 2014
End Date:May 8, 2018

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Trial Summary
Trial Overview
Inclusion Criteria

Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits

Non-randomized, multi-center, prospective surveillance study to investigate and assess the
residual risks, and to confirm the currently established safety and performance of the Melody
TPV PB1016.


Inclusion Criteria:

- Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU)
indications at time of study enrollment

- Patient (or patient's legally authorized representative) is willing to consent to
participate in the study and will commit to completion of all follow-up requirements.

Exclusion Criteria:

- Implantation in the aortic, tricuspid, or mitral position

- Venous anatomy unable to accommodate a 22-Fr size introducer sheath

- Obstruction of the central veins

- Clinical or biological signs of infection including active endocarditis

- History of intravenous substance abuse

- Currently participating in an investigational drug or device study
We found this trial at
6
sites
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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Nationwide Children's Hospital
700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: John P. Cheatham, MD
Phone: 614-722-2459
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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University of California at Los Angeles
Los Angeles, California 90095
310-825-4321
Principal Investigator: Daniel Levi, MD
Phone: 310-825-5296
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Children's Hospital of Michigan
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Principal Investigator: Daniel Turner, MD
Phone: 313-745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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Landes-Kinderklinik
Linz, 4020
Principal Investigator: Roland Gitter, MD
Phone: 0732/6923-24746
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Linz,
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Seattle Childrens and Regional Hospital
Seattle, Washington 98105
Principal Investigator: Thomas Jones, MD
Phone: 206-987-2266
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Seattle, WA
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