Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2012-09-30
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Trifecta aortic xenograft
The Trifecta aortic xenograft is implanted in these patients.
Aortic xenograft
After randomization, the aortic xenograft is implanted in the standard fashion
Magna Ease aortic xenograft
The Magna Ease aortic xenograft is implanted in these patients.
Aortic xenograft
After randomization, the aortic xenograft is implanted in the standard fashion
Interventions
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Aortic xenograft
After randomization, the aortic xenograft is implanted in the standard fashion
Eligibility Criteria
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Inclusion Criteria
* Elective aortic valve replacement in patients with predominant aortic stenosis
* including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
* Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
* Native German speakers (quality of life questionnaire in German language)
Exclusion Criteria
* Concomitant aortic regurgitation \> 2°
* Endocarditis
* LVEF \<40%
* Concomitant other valve surgery
* s/p valve surgery
* Contraindication for stress echocardiography
18 Years
75 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Kerckhoff Klinik
OTHER
Responsible Party
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Locations
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Kerckhoff Klinik
Bad Nauheim, , Germany
Countries
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Other Identifiers
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COTRIP
Identifier Type: -
Identifier Source: org_study_id
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