Comparison of Two Pericardial Bioprostheses in AVR

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

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.

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.

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