Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
1151 participants
OBSERVATIONAL
2011-01-31
2021-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Trifecta™ Valve Group
Subjects implanted with the Trifecta™ aortic bioprosthesis.
Trifecta™ aortic bioprosthesis
Surgical aortic valve replacement with the Trifecta™ valve.
Interventions
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Trifecta™ aortic bioprosthesis
Surgical aortic valve replacement with the Trifecta™ valve.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Sven Lehmann
Role: PRINCIPAL_INVESTIGATOR
Universitat Herzzentrum Leipzig
Locations
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Universitat Herzzentrum Leipzig
Leipzig, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CS-10-012-EU-TV
Identifier Type: -
Identifier Source: org_study_id