Comparison of Two Pericardial Bioprostheses in AVR

Seoul National University Hospital140 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Aortic Valve Disease

Interventions

AVR with AVALUSDEVICE

aortic valve replacement with AVALUS bioprosthesis

AVR with CEPMEDEVICE

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

Seoul National University Bundang Hospital

Seongnam, South Korea

Seoul National University Hospital

Seoul, South Korea