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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014