NCT03796442

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

January 23, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
8 months until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
Last Updated

February 8, 2023

Status Verified

January 1, 2023

Enrollment Period

2.3 years

First QC Date

January 1, 2019

Results QC Date

October 31, 2022

Last Update Submit

January 20, 2023

Conditions

Aortic Valve Disease

Keywords

aortic valve replacementbioprosthesis

Outcome Measures

Primary Outcomes (1)

  • Transvalvular Mean Pressure Gradient (mPG)

    transvalvular mean pressure gradient measured by trans-thoracic echocardiography

    at postoperative 1 year

Secondary Outcomes (6)

  • Effective Orifice Area (EOA)

    at postoperative 1 year

  • Number of Participants With Op Mortality

    at postoperative 30 days or at the time of discharge

  • Number of Participants With Op Morbidities

    at postoperative 1 year

  • Number of Participants With All-cause Mortality

    at postoperative 1 year

  • Number of Participants With Cardiac Death

    at postoperative 1 year

  • +1 more secondary outcomes

Study Arms (2)

AVALUS group

EXPERIMENTAL

patients who will undergo aortic valve replacement with Avalus bioprosthesis

Device: AVR with AVALUS

CEPME group

ACTIVE COMPARATOR

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

Device: AVR with CEPME

Interventions

AVR with AVALUSDEVICE

aortic valve replacement with AVALUS bioprosthesis

AVALUS group
AVR with CEPMEDEVICE

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

CEPME group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who are going to undergo aortic valve replacement with bioprosthesis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (2)

  • Sohn SH, Kang Y, Kim JS, Choi JW, Lee JH, Kim JS, Lim C, Hwang HY. A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2025 Mar;73(2):132-140. doi: 10.1055/a-2199-2087. Epub 2023 Oct 26.

    PMID: 37884030DERIVED

  • Sohn SH, Kim JS, Choi JW, Lee JH, Kim JS, Lim C, Hwang HY. Preliminary Report from a Randomized Controlled Trial Comparing Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2023 Dec;71(8):648-655. doi: 10.1055/s-0042-1753494. Epub 2022 Aug 2.

    PMID: 35917824DERIVED

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Prof. Ho Young Hwang
Organization
Seoul National University Hospital
scalpel@snu.ac.kr
00-82-2-2072-3020

Study Officials

  • Ho Young Hwang, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 1, 2019

First Posted

January 8, 2019

Study Start

January 23, 2019

Primary Completion

May 13, 2021

Study Completion

May 31, 2022

Last Updated

February 8, 2023

Results First Posted

February 8, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

IPD will not be shared because it is not allowed by our institutional IRB.

Locations

KR(2)