NCT03796442

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	AVR with AVALUS	aortic valve replacement with AVALUS bioprosthesis
DEVICE	AVR with CEPME	aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Timeline

• Start date: 2019-01-23
• Primary completion: 2021-05-13
• Completion: 2022-05-31
• First posted: 2019-01-08
• Last updated: 2023-02-08
• Results posted: 2023-02-08

Locations

2 sites across 1 country: South Korea

Regulatory

• FDA-regulated device study