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

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00475267

Purpose

The purpose of this study is 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

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:

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 ]
Establish adverse event rates. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	May 2007
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Intended as a replacement for a diseased, damaged, or malfunctioning 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.

Eligibility

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

Criteria

Inclusion Criteria:

Requires aortic valve replacement (heart surgery such as bypass is allowed at the same time).
Legal age.
Signed informed consent prior to surgery.
Willing to complete all follow-up requirements.

Exclusion Criteria:

Pregnant or nursing women.
Have already had a valve replaced other than the aortic valve.
Needs another valve replaced.
Cannot return for required follow-up visits.
Have active endocarditis.
Acute preoperative neurological event (such as a stroke).
Renal dialysis.
History of substance abuse within one year, or a prison inmate.
Participating in another study.
Life expectancy less than two years.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475267

Locations

Canada, British Columbia
University of British Columbia, St. Paul's Hospital	Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Gail R Vicente, MSc 604-806-9981 grvicente@providencehealth.bc.ca
Contact: Cindy A Bryson, BMLSc 604-806-9148 cbryson@providencehealth.bc.ca
Principal Investigator: Anson Cheung, MD
Sub-Investigator: W R Eric Jamieson, MD
Sub-Investigator: James G Abel, MD
Sub-Investigator: Samuel V Lichtenstein, MD
Sub-Investigator: Ahmad Poostizadeh, MD
Sub-Investigator: Jian Ye, MD
Canada, Nova Scotia
QEII Health Sciences Center	Recruiting
2269-1796 Summer St., Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Janice E. MacIsaac, RN 902-473-5780 macisaacje@cdha.nshealth.ca
Principal Investigator: Jeremy R. Wood, MD
Canada, Ontario
University Health Network - Toronto General Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Suzanne Hemeon, RN 416-340-3491 suzanne.hemeon@uhn.on.ca
Contact: Maggie Szeto, HBSc 416-340-3491 maggie.szeto@uhn.on.ca
Principal Investigator: Vivek Rao, MD, PhD
Canada, Quebec
Montreal Heart Institute	Recruiting
Montreal, Quebec, Canada, H1T 1C8
Contact: Manon Bellemare, Coordinator 514-376-3330 ext 3613 manon.bellemare@icm-mhi.org
Contact: Genevieve Brassard, Administrative Agent 514-376-3330 ext 3085 cliniquedevalves@icm-mhi.org
Principal Investigator: Michel Pellerin, Principal Investigator
Hôpital Laval	Recruiting
Québec, Quebec, Canada, GN 4G5
Contact: Louise Côté, RN 418-656-8711 ext 5542 Louise.Cote@crhl.ulaval.ca
Contact: Martine Fleury, Secretary 418-656-8711 ext 5649 martine.fleury@crhl.ulaval.ca
Principal Investigator: Eric Charbonneau, MD
Sub-Investigator: Pierre Voisine, MD
Sub-Investigator: Richard Baillot, MD
Sub-Investigator: Eric Dumont, MD
Sub-Investigator: Daniel P. Boyle, MD
Sub-Investigator: Patrick Mathieu, MD
Sub-Investigator: François Dajenais, MD
Sub-Investigator: Mario Senechol
Sub-Investigator: Jacques Metras, MD

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Hartzell Schaff, MD

Mayo Clinic

More Information

Responsible Party:	St. Jude Medical, Inc., Cardiovascular Division ( Senior Director, Clinical Affairs )
Study ID Numbers:	CS0601
Study First Received:	May 16, 2007
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00475267
Health Authority:	Canada: Health Canada

Keywords provided by St. Jude Medical:

aortic valve
heart valve
tissue valve
bioprosthesis
valve disorder

valve disease
cardiac surgery
aortic valve stenosis
aortic valve regurgitation

Study placed in the following topic categories:

Heart Diseases
Aortic Valve Insufficiency
Constriction, Pathologic

Aortic valve stenosis
Aortic Valve Stenosis
Heart Valve Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases
Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on January 16, 2009