Comparison of TrIfecta and Perimount Magna Ease

Study Overview
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Brief Summary
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The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.

Official Title
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Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease

Conditions
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Aortic Xenograft Hemodynamics

Intervention / Treatment
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* Device: Aortic xenograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 75 years 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: Isolated aortic regurgitation Concomitant aortic regurgitation > 2° Endocarditis LVEF <40% Concomitant other valve surgery s/p valve surgery Contraindication for stress echocardiography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trifecta aortic xenograft<br>The Trifecta aortic xenograft is implanted in these patients. | Device: Aortic xenograft<br>* After randomization, the aortic xenograft is implanted in the standard fashion<br>|
| Active Comparator: Magna Ease aortic xenograft<br>The Magna Ease aortic xenograft is implanted in these patients. | Device: Aortic xenograft<br>* After randomization, the aortic xenograft is implanted in the standard fashion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transprosthetic pressure gradient at stress exercise echocardiography |  | Echo at follow up stress echo (at 10 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transprosthetic pressure gradient at discharge echo |  | Echo at discharge (usually postoperative day 5 to 7) | 
| Left ventricular mass regression calculated by echocardiography (gram) |  | Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months) | 
| Quality of life using the EQ-5D-3L questionnaire |  | 1 to 5 days before surgery and at follow up (10 months) | 
| BNP plasma level |  | 1 to 5 days before surgery and at follow up (10 months) |