Trifecta Durability Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256710
Recruitment Status : Active, not recruiting
First Posted : December 8, 2010
Last Update Posted : April 19, 2018
Information provided by (Responsible Party):
St. Jude Medical

December 7, 2010
December 8, 2010
April 19, 2018
January 2011
June 2021   (Final data collection date for primary outcome measure)
Actuarial freedom from reoperation due to Structural Valve Deterioration [ Time Frame: 10 years ]
Same as current
Complete list of historical versions of study NCT01256710 on Archive Site
  • Actuarial survival rate [ Time Frame: 10 years ]
  • Freedom from valve related death [ Time Frame: 10 years ]
  • Freedom from structural valve deterioration [ Time Frame: 10 years ]
Same as current
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Not Provided
Trifecta Durability Study
Trifecta Durability Study
The purpose of the SJM International, Inc. sponsored "Trifecta™ Durability Study", is to evaluate the long-term durability of the Trifecta™ valve.
Not Provided
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients that are candicate for implantation or have been implanted over the past 9 months with a St. Jude Medical Trifecta heart valve.
Aortic Valve Disorder
Device: Implantation of the Trifecta Valve
Implantation of the bioprothesis valve, Trifecta Valve
Trifecta Valve Group
Intervention: Device: Implantation of the Trifecta Valve
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
June 2021
June 2021   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients implanted for less than 9 months, or candidate for implantation with a St Jude Medical Trifecta valve, as per current guidelines
  • Patient requires aortic valve replacement.
  • Patient is legal age in host country.
  • Patients must be able and willing to provide written informed consent to participate in this investigation
  • Patients must be willing and able to comply with all follow-up requirements

Exclusion Criteria:

  • Patients with contraindication for cardiac surgery
  • Patients who are pregnant.
  • Patient is unwilling to or has an inability that reduces his mobility in order to attend the required follow-up visits.
  • Patient has active endocarditis
  • Patient has had an acute preoperative neurological event defined as patient has not returned to baseline 30 days prior to the planned valve implantation surgery.
  • Patient is undergoing renal dialysis.
  • Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
  • Patient has a documented thrombus in left atrium or left ventricle.
  • Patient had in the past mitral or tricuspid valve replacement.
  • Patient needs mitral and/or tricuspid valve replacement.
  • Patient has an Ejection Fraction < 25%
  • Patient had the Trifecta™ valve implanted as part of this study, but then had the device explanted
  • Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
  • Patient has a life expectancy less than two years.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Plan to Share IPD: No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Sven Lehmann Universitat Herzzentrum Leipzig
St. Jude Medical
April 2018