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
  Purpose

The purpose of the SJM International, Inc. sponsored "Trifecta™ Durability Study", is to evaluate the long-term durability of the Trifecta™ valve.


Condition Intervention
Aortic Valve
Device: Implantation of the Trifecta Valve

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Trifecta Durability Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Actuarial freedom from reoperation due to Structural Valve Deterioration [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 801
Study Start Date: January 2011
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Trifecta Valve Group Device: Implantation of the Trifecta Valve
Implantation of the bioprothesis valve, Trifecta Valve

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that are candicate for implantation or have been implanted over the past 9 months with a St. Jude Medical Trifecta heart valve.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256710

Locations
Germany
Universitat Herzzentrum Leipzig
Leipzig, Germany, 04289
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Michael A Borger, Prof. Universitat Herzzentrum Leipzig
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01256710     History of Changes
Other Study ID Numbers: CS-10-012-EU-TV
Study First Received: December 7, 2010
Last Updated: October 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 17, 2014