Comparison of Two Pericardial Bioprostheses in AVR

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Aortic Valve Disease

Clinical Trial Details

NCT number	NCT03796442
Study type	Interventional
Source	Seoul National University Hospital
Contact
Status	Completed
Phase	N/A
Start date	January 23, 2019
Completion date	May 31, 2022

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