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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: AVR with AVALUS; Device: AVR with CEPME

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AVALUS group; patients who will undergo aortic valve replacement with Avalus bioprosthesis	Device: AVR with AVALUS; aortic valve replacement with AVALUS bioprosthesis
ACTIVE_COMPARATOR: CEPME group; patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis	Device: AVR with CEPME; aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transvalvular Mean Pressure Gradient (mPG)	transvalvular mean pressure gradient measured by trans-thoracic echocardiography	at postoperative 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective Orifice Area (EOA)	effective orifice area measured by trans-thoracic echocardiography	at postoperative 1 year
Number of Participants With Op Mortality	any death within 30 days after surgery or during the same hospital admission	at postoperative 30 days or at the time of discharge
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	at postoperative 1 year
Number of Participants With All-cause Mortality	patients who died from any cause	at postoperative 1 year
Number of Participants With Cardiac Death	Any death related to cardiac events, including sudden death during follow-up	at postoperative 1 year
Number of Participants With Aortic Valve-related Events	valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation	at postoperative 1 year

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 23, 2019
• Primary Completion (ACTUAL): May 13, 2021
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: January 1, 2019
• First Submitted That Met QC Criteria: January 7, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: aortic valve replacement; bioprosthesis
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: D-1812-024-991

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared because it is not allowed by our institutional IRB.

Drug and device information, study documents

• 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