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Comparison of Two Pericardial Bioprostheses in AVR

Primary Purpose

Aortic Valve Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AVR with AVALUS
AVR with CEPME
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring aortic valve replacement, bioprosthesis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AVALUS group

CEPME group

Arm Description

patients who will undergo aortic valve replacement with Avalus bioprosthesis

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

Outcomes

Primary Outcome Measures

Transvalvular Mean Pressure Gradient (mPG)
transvalvular mean pressure gradient measured by trans-thoracic echocardiography

Secondary Outcome Measures

Effective Orifice Area (EOA)
effective orifice area measured by trans-thoracic echocardiography
Number of Participants With Op Mortality
any death within 30 days after surgery or during the same hospital admission
Number of Participants With Op Morbidities
low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection
Number of Participants With All-cause Mortality
patients who died from any cause
Number of Participants With Cardiac Death
Any death related to cardiac events, including sudden death during follow-up
Number of Participants With Aortic Valve-related Events
valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation

Full Information

First Posted
January 1, 2019
Last Updated
January 20, 2023
Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03796442
Brief Title
Comparison of Two Pericardial Bioprostheses in AVR
Official Title
Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2019 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
aortic valve replacement, bioprosthesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AVALUS group
Arm Type
Experimental
Arm Description
patients who will undergo aortic valve replacement with Avalus bioprosthesis
Arm Title
CEPME group
Arm Type
Active Comparator
Arm Description
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
Intervention Type
Device
Intervention Name(s)
AVR with AVALUS
Intervention Description
aortic valve replacement with AVALUS bioprosthesis
Intervention Type
Device
Intervention Name(s)
AVR with CEPME
Intervention Description
aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
Primary Outcome Measure Information:
Title
Transvalvular Mean Pressure Gradient (mPG)
Description
transvalvular mean pressure gradient measured by trans-thoracic echocardiography
Time Frame
at postoperative 1 year
Secondary Outcome Measure Information:
Title
Effective Orifice Area (EOA)
Description
effective orifice area measured by trans-thoracic echocardiography
Time Frame
at postoperative 1 year
Title
Number of Participants With Op Mortality
Description
any death within 30 days after surgery or during the same hospital admission
Time Frame
at postoperative 30 days or at the time of discharge
Title
Number of Participants With Op Morbidities
Description
low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection
Time Frame
at postoperative 1 year
Title
Number of Participants With All-cause Mortality
Description
patients who died from any cause
Time Frame
at postoperative 1 year
Title
Number of Participants With Cardiac Death
Description
Any death related to cardiac events, including sudden death during follow-up
Time Frame
at postoperative 1 year
Title
Number of Participants With Aortic Valve-related Events
Description
valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation
Time Frame
at postoperative 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ho Young Hwang, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared because it is not allowed by our institutional IRB.
Citations:
PubMed Identifier
35917824
Citation
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. 2022 Aug 2. doi: 10.1055/s-0042-1753494. Online ahead of print.
Results Reference
derived

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Comparison of Two Pericardial Bioprostheses in AVR

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