Comparison of Two Pericardial Bioprostheses in AVR

Not Applicable

Completed

• Conditions: Aortic Valve Disease
• Interventions: Device: AVR with AVALUS; Device: AVR with CEPME

• Registration Number: NCT03796442
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2019-01-01
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Study Start: 2019-01-23
• Primary Completion: 2021-05-13
• Study Completion: 2022-05-31
• Results First Submitted: 2022-10-31
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVALUS group	AVR with AVALUS	patients who will undergo aortic valve replacement with Avalus bioprosthesis
CEPME group	AVR with CEPME	patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Primary Outcome Measures

Name	Time	Method
Transvalvular Mean Pressure Gradient (mPG)	at postoperative 1 year	transvalvular mean pressure gradient measured by trans-thoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Op Morbidities	at postoperative 1 year	low cardiac output syndrome, bleeding reoperation, perioperative myocardial infarction, stroke, acute kidney injury, respiratory complication, new onset atrial fibrillation, mediastinitis, surgical wound infection
Effective Orifice Area (EOA)	at postoperative 1 year	effective orifice area measured by trans-thoracic echocardiography
Number of Participants With Op Mortality	at postoperative 30 days or at the time of discharge	any death within 30 days after surgery or during the same hospital admission
Number of Participants With All-cause Mortality	at postoperative 1 year	patients who died from any cause
Number of Participants With Cardiac Death	at postoperative 1 year	Any death related to cardiac events, including sudden death during follow-up
Number of Participants With Aortic Valve-related Events	at postoperative 1 year	valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of