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Sponsored by: |
St. Jude Medical |
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Information provided by: | St. Jude Medical |
ClinicalTrials.gov Identifier: | NCT00475709 |
To confirm the clinical safety and effectiveness of the Trifecta valve.
Condition | Intervention |
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Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence Aortic Valve Stenosis |
Device: Trifecta aortic heart valve Device: Trifecta Aortic Heart Valve |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Observational, Prospective Evaluation of the Trifecta Valve |
Estimated Enrollment: | 800 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Trifecta Aortic Heart Valve: Experimental
All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
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Device: Trifecta aortic heart valve
Replacement of a diseased, damaged, or malfunctioning aortic heart valve
Device: Trifecta Aortic Heart Valve
Surgical replacement of the aortic valve with the Trifecta Aortic Heart Valve.
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The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study designed to evaluate the safety and effectiveness of the Trifecta valve.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
USC Keck School of Medicine, Dept. of Cardiothoracic Surgery, USC University Hospital | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Vaughn A. Starnes, MD Phone Email@Email.com | |
Contact: Mark J. Cunningham, MD Phone Email@Email.com | |
Principal Investigator: Vaughn A. Starnes, MD | |
Sub-Investigator: Mark J. Cunningham, MD | |
United States, Florida | |
Sarasota Memorial Hospital/Clinical Research Center | Recruiting |
Sarasota, Florida, United States, 34239 | |
Contact: Amanda J. Miller, RN, BSN 941-917-5024 Amanda-Miller@smh.com | |
Contact: Kathleen A. Mack, RN, MA 941-917-1298 Kathleen-Mack@smh.com | |
Sub-Investigator: Martin L. Beggs, MD | |
Sub-Investigator: Joseph C. Schiro, MD | |
Principal Investigator: Thomas F. Kelly, MD | |
Sub-Investigator: Stephen Dziadik, PA-C | |
United States, Illinois | |
Loyola University Medical Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Mamdough Bakhos, MD 708-327-2503 mbakhos@LUMC.edu | |
Contact: Sally B. Botkin, RN, BS, MPH 708-327-2503 sbotkin@LUMC.edu | |
Principal Investigator: Mamdouh Bakhos | |
Sub-Investigator: Jeffrey P. Schwartz | |
United States, Michigan | |
William Beaumont Hospital | Recruiting |
Royal Oak, Michigan, United States, 48073 | |
Contact: Dawn M Mitchell, RN, BSN 248-898-6551 dammitchell@beaumonthospital.com | |
Contact: Brian Walker, RN, BSN, CCRN, CCRP 248-551-7930 bwalker@beaumont.edu | |
Principal Investigator: Marc P Sakwa, MD | |
Sub-Investigator: Francis L Shannon, MD | |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Deborah Rolbiecki 507-255-5027 rolbiecki.deborah@mayo.edu | |
Principal Investigator: Hartzell Schaff, MD | |
Sub-Investigator: Harold Burkhart, MD | |
Sub-Investigator: Richard Daly, MD | |
Sub-Investigator: Joseph Dearani, MD | |
Sub-Investigator: Christopher McGregor, MD | |
Sub-Investigator: Charles Mullany, MD | |
Sub-Investigator: Thomas Orszulak, MD | |
Sub-Investigator: Soon Park, MD | |
Sub-Investigator: Thoralf Sundt, MD | |
Sub-Investigator: Rakesh Suri, MD | |
Abbott Northwestern Hospital | Recruiting |
Minneapolis, Minnesota, United States, 55407 | |
Contact: Peg A. Demmer, RN, BSN, CCRC 612-863-6066 peg.a.demmer@allina.com | |
Contact: Sara D. Olson, RN, BSN 612-863-7601 sara.olson@allina.com | |
Principal Investigator: Vib Kshettry, MD | |
Sub-Investigator: Thomas Flavin, MD | |
Sub-Investigator: Timothy Kroshus, MD | |
Sub-Investigator: Frasier Eales, MD | |
United States, New York | |
NYU Medical Center | Completed |
New York, New York, United States, 10016 | |
Columbia University Medical Center | Completed |
New York, New York, United States, 10032 | |
United States, North Carolina | |
Duke University Medical Center | Recruiting |
Durham, North Carolina, United States, 27710 | |
Contact: Donald D Glower, MD 919-681-5789 glowe001@mc.duke.edu | |
Contact: Terry L Ainsworth, RN, MS 919-668-2382 ainsw001@mc.duke.edu | |
Principal Investigator: Donald D. Glower, MD | |
Sub-Investigator: Robert D. Davis, MD | |
Sub-Investigator: Carmelo A. Milano, MD | |
Sub-Investigator: Shu S. Linn, MD, PhD | |
Sub-Investigator: James E. Lowe, MD | |
Sub-Investigator: Robert D. Davis, MD | |
Sub-Investigator: Peter K. Smith, MD | |
Sub-Investigator: George C. Hughes, MD | |
Mission Hospitals | Recruiting |
Asheville, North Carolina, United States, 28801 | |
Contact: Mission Hospitals Research Institute 828-213-7055 | |
Principal Investigator: Mark Groh, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Robbi Palumbo, RN 216-444-8774 palumbr@ccf.org | |
Contact: Kathy Reynolds, RN 216-444-6232 reynolk@ccf.org | |
Principal Investigator: A. Marc Gillinov, MD | |
Sub-Investigator: Richard A. Grimm, MD, DO | |
Sub-Investigator: Thomas Mihaljevic, MD | |
Sub-Investigator: Jose L. Navia, MD | |
Sub-Investigator: Gosta B. Pettersson, MD | |
Sub-Investigator: Eric E. Roselli, MD | |
Sub-Investigator: Joseph F. Sabik, MD | |
Sub-Investigator: Nicholas G. Smedira, MD | |
Sub-Investigator: Gonzalo V. Gonzalez-Stawinski, MD | |
Sub-Investigator: Lars G. Svensson, MD | |
Sub-Investigator: Maran Thamilarasan, MD | |
United States, Pennsylvania | |
University of Pennsylvania Health System | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Tyler J. Wallen, BA 215-349-5752 tyler.wallen@uphs.upenn.edu | |
Contact: Elizabeth K. Walsh, RN 215-662-4289 walshli@uphs.upenn.edu | |
Principal Investigator: Joseph E. Bavaria, MD | |
Sub-Investigator: Michael Acker, MD | |
Sub-Investigator: Albert Cheung, MD | |
Sub-Investigator: W. Clark Hargrove, MD | |
Sub-Investigator: Martin Kean, MD | |
Sub-Investigator: Rohinton Morris, MD | |
Sub-Investigator: Y. Joseph Woo, MD | |
Sub-Investigator: Wilson Szeto, MD | |
Main Line Health Heart Center | Recruiting |
Wynnewood, Pennsylvania, United States, 19096 | |
Contact: Peter R Kowey, MD 610-649-6980 koweypr@mlhheart.org | |
Contact: Ann Marie R Chikowski, RN, BSN, CCRC 610-645-8579 chikowskia@mlhheart.org | |
Principal Investigator: Scott M. Goldman, MD | |
Sub-Investigator: Francis D. Ferdinand, MD | |
Sub-Investigator: Louis E. Samuels, MD | |
Sub-Investigator: Francis Sutter, MD | |
United States, Tennessee | |
Vanderbilt Medical Center | Recruiting |
Nashville, Tennessee, United States, 37212 | |
Contact: Mary D. Gordon, RN 615-936-8377 mary.d.gordon@vanderbilt.edu | |
Contact: Lynn M. Blair-Anton, BSN 615-343-4349 lynn.blair-anton@vanderbilt.edu | |
Principal Investigator: Michael R. Petracek, MD | |
United States, Texas | |
Baylor College of Medicine | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Marisa Martinovich, BS 832-355-9927 martinov@bcm.edu | |
Contact: Susan Green, MPH 832-355-9962 sgreen@bcm.edu | |
Principal Investigator: Joseph S. Coselli, MD | |
Sub-Investigator: Scott A. LeMaire, MD | |
Cardiothoracic and Vascular Surgeons | Recruiting |
Austin, Texas, United States, 78756 | |
Contact: Donna M. Johnson, BSMT, BB(ASCP), CCRC 512-459-3300 donna@ctvstexas.com | |
Principal Investigator: Stephen J. Dewan, MD | |
Sub-Investigator: John D. Oswalt, MD | |
Sub-Investigator: Michael C. Mueller, MD | |
Sub-Investigator: Andrew T. Hume, MD | |
Sub-Investigator: Mark C. Felger, MD | |
Sub-Investigator: William F. Kessler, MD | |
Sub-Investigator: Staton L. Awtrey, MD | |
United States, Utah | |
Intermountain Medical Center | Recruiting |
Murray, Utah, United States, 84157 | |
Contact: Jean Flores, RN 801-507-3600 jean.flores@intermountainmail.org | |
Principal Investigator: Kent W. Jones, MD | |
Sub-Investigator: James W. Long, MD | |
Sub-Investigator: Stephen E. Clayson, MD | |
Sub-Investigator: Bruce B. Reid, MD | |
United States, Wisconsin | |
Aurora St. Luke's Medical Center | Recruiting |
Milwaukee, Wisconsin, United States, 53201 | |
Contact: Jennifer Cooper, RN 414-385-2504 jennifer.cooper@aurora.org | |
Contact: Cheryl A. Zywicki, RN, CCRC 414-385-2474 cheryl.zywicki@aurora.org | |
Principal Investigator: David C. Kress, MD | |
Sub-Investigator: Paul H. Werner, MD |
Principal Investigator: | Hartzell Schaff, MD | Mayo Clinic |
Responsible Party: | St. Jude Medical, Inc. ( Senior Director, Clinical ) |
Study ID Numbers: | CS0501 |
Study First Received: | May 16, 2007 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00475709 History of Changes |
Health Authority: | United States: Food and Drug Administration |
aortic valve heart valve tissue valve bioprosthesis valve disorder |
valve disease cardiac surgery aortic valve stenosis aortic valve regurgitation |
Heart Diseases Aortic Valve Insufficiency Constriction, Pathologic Aortic Valve Stenosis Heart Valve Diseases |
Heart Diseases Aortic Valve Insufficiency Cardiovascular Diseases |
Aortic Valve Stenosis Ventricular Outflow Obstruction Heart Valve Diseases |