Comparison of Two Pericardial Bioprostheses in AVR

Study Overview
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Brief Summary
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The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.

Detailed Description
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This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier Edwards Perimount Magna Ease according to the randomization result. The primary end point is postoperative 1-year transvalvular mean pressure gradient. The secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events.

Official Title
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Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial

Conditions
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Aortic Valve Disease

Intervention / Treatment
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* Device: AVR with AVALUS
* Device: AVR with CEPME


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who are going to undergo aortic valve replacement with bioprosthesis Exclusion Criteria: heart failure with severe LV dysfunction (LV EF <30%) active infective endocarditis with other critical cardiovascular disease (e.g. acute aortic dissection) with other critical comorbities by which the expected life span is less than 1 year inadequate participant by the researcher's discretion

Ages Eligible for Study
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Minimum Age: 19 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 |
| --- | --- |
| Experimental: AVALUS group<br>patients who will undergo aortic valve replacement with Avalus bioprosthesis | Device: AVR with AVALUS<br>* aortic valve replacement with AVALUS bioprosthesis<br>|
| Active Comparator: CEPME group<br>patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis | Device: AVR with CEPME<br>* aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transvalvular Mean Pressure Gradient (mPG) | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | at postoperative 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Orifice Area (EOA) | effective orifice area measured by trans-thoracic echocardiography | at postoperative 1 year | 
| Number of Participants With Op Mortality | any death within 30 days after surgery or during the same hospital admission | at postoperative 30 days or at the time of discharge | 
| Number of Participants With Op Morbidities | low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection | at postoperative 1 year | 
| Number of Participants With All-cause Mortality | patients who died from any cause | at postoperative 1 year | 
| Number of Participants With Cardiac Death | Any death related to cardiac events, including sudden death during follow-up | at postoperative 1 year | 
| Number of Participants With Aortic Valve-related Events | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation | at postoperative 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aortic valve replacement, bioprosthesis