Aortic Valve Replacement With Trifecta(TM) - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00475709

Purpose

To confirm the clinical safety and effectiveness of the Trifecta valve.

Condition	Intervention
Aortic Valve Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence Aortic Valve Stenosis	Device: Trifecta aortic heart valve Device: Trifecta Aortic Heart Valve

MedlinePlus related topics: Surgery

U.S. FDA Resources

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

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Establish adverse event rates. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
Characterize patient NYHA functional classification status. [ Time Frame: At required follow-up intervals ] [ Designated as safety issue: No ]
Characterize the hemodynamic performance of the valve. [ Time Frame: At required follow-up intervals ] [ Designated as safety issue: No ]

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
Trifecta Aortic Heart Valve: Experimental All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.	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.

Detailed Description:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475709

Locations

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

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Hartzell Schaff, MD

Mayo Clinic

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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