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Comparison of the investigational device exemption and post-approval trials of the Melody transcatheter pulmonary valve
Authors:Jacqueline Kreutzer MD  Aimee K. Armstrong MD  Jonathan J. Rome MD  Thomas M. Zellers MD  David T. Balzer MD  Jeffrey D. Zampi MD  Allison K. Cabalka MD  Alexander J. Javois MD  Daniel R. Turner MD  Robert G. Gray MD  John W. Moore MD  Shicheng Weng MS  Thomas K. Jones MD  Danyal M. Khan MD  Julie A. Vincent MD  William E. Hellenbrand MD  John P. Cheatham MD  Lisa J. Bergersen MD  MPH  Doff B. McElhinney MD
Affiliation:1. Division of Cardiology, Department of Pediatrics, University of Pittsburgh School of Medicine, UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, USA;2. The Heart Center, Nationwide Children's Hospital, Columbus, Ohio, USA;3. Division of Cardiology, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA;4. Division of Cardiology, Department of Pediatrics, University of Texas Southwestern and the Heart Center at Children's Health, Dallas, Texas, USA;5. Division of Pediatric Cardiology, Washington University School of Medicine/Saint Louis Children's Hospital, St. Louis, Missouri, USA;6. Division of Pediatric Cardiology, University of Michigan Medical School, Ann Arbor, Michigan, USA;7. Division of Cardiology, Mayo Clinic, Rochester, Minnesota, USA;8. Advocate Children's Hospital, Section of Pediatric Cardiology, Advocate Children's Hospital, University of Illinois Hospital, Chicago, Illinois, USA;9. Division of Cardiology, Carman and Ann Adams Department of Pediatrics, Children's Hospital of Michigan, Detroit, Michigan, USA;10. Department of Pediatrics, Division of Pediatric Cardiology, University of Utah, Salt Lake City, Utah, USA;11. Department of Pediatric Cardiology, Rady Children's Hospital, UC San Diego, San Diego, California, USA;12. Department of Biostatistics, Medtronic, Framingham, Massachusetts, USA;13. Department of Cardiology, Seattle Children's Hospital, Seattle, Washington, USA;14. The Heart Program, Nicklaus Children's Hospital, Miami, Florida, USA;15. Division of Pediatric Cardiology, Columbia University Medical Center, New York, New York, USA;16. Department of Pediatrics (Cardiology), Yale University School of Medicine, New Haven, Connecticut, USA;17. Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts, USA;18. Department of Cardiothoracic Surgery, Lucille Packard Children's Hospital, Stanford University School of Medicine, Palo Alto, California, USA
Abstract:
Keywords:pulmonary heart disease  tetralogy of Fallot  transcatheter pulmonary valve replacement
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