Trifecta Durability Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01256710
First received: December 7, 2010
Last updated: October 11, 2013
Last verified: September 2011

December 7, 2010
October 11, 2013
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01256710 on ClinicalTrials.gov Archive Site
  • Actuarial survival rate [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Freedom from valve related death [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Freedom from structural valve deterioration [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
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
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
801
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01256710
CS-10-012-EU-TV
No
St. Jude Medical
St. Jude Medical
Not Provided
Principal Investigator: Michael A Borger, Prof. Universitat Herzzentrum Leipzig
St. Jude Medical
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP