Brief Title
Aortic Valve Replacement With Trifecta(TM)
Official Title
An Observational, Prospective Evaluation of the Trifecta Valve
Brief Summary
To confirm the clinical safety and effectiveness of the Trifecta 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.
Study Type
Interventional
Primary Outcome
Late Adverse Event Rates
Condition
Aortic Valve Insufficiency
Intervention
Trifecta Aortic Heart Valve
Study Arms / Comparison Groups
Trifecta Aortic Heart Valve
Description: All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1022
Start Date
June 2007
Completion Date
January 2012
Primary Completion Date
July 2010
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Hartzell Schaff, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00475709
Organization ID
CS0501
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
Hartzell Schaff, MD, Principal Investigator, Mayo Clinic
Verification Date
February 2019