Comparison of Two Pericardial Bioprostheses in AVR

Seoul National University

Status: Completed

Conditions: Aortic Valve Disease

Treatments: Device: AVR with CEPME; Device: AVR with AVALUS

Study type: Interventional

Funder types: Other

Identifiers

NCT03796442

D-1812-024-991

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

AVALUS group

Experimental group

Description:

patients who will undergo aortic valve replacement with Avalus bioprosthesis

Treatment:

Device: AVR with AVALUS

CEPME group

Active Comparator group

Description:

patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Treatment:

Device: AVR with CEPME