Status:
TERMINATED
Trifecta™ Durability Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
18+ years
Brief Summary
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve. Th...
Eligibility Criteria
Inclusion
- Patients implanted for less than 9 months with a Trifecta™ valve, or patients who are candidates for implant with a 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
- 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.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 12 2021
Estimated Enrollment :
1151 Patients enrolled
Trial Details
Trial ID
NCT01256710
Start Date
January 1 2011
End Date
March 12 2021
Last Update
November 22 2023
Active Locations (1)
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1
Universitat Herzzentrum Leipzig
Leipzig, Germany, 04289