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Comparison of Two Pericardial Bioprostheses in AVR

NCT03796442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-02-08

Study results available
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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.

Conditions

  • Aortic Valve Disease

Interventions

DEVICE

AVR with AVALUS

aortic valve replacement with AVALUS bioprosthesis

DEVICE

AVR with CEPME

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Ho Young Hwang, MD, PhD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-23
Primary Completion
2021-05-13
Completion
2022-05-31
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03796442 on ClinicalTrials.gov