Comparison of Two Pericardial Bioprostheses in AVR

Aortic Valve Disease Clinical Trial

Official title:

Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03796442
• Other study ID #: D-1812-024-991
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 31, 2022
• Est. primary completion date: May 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Device:
• AVR with AVALUS
aortic valve replacement with AVALUS bioprosthesis
• AVR with CEPME
aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transvalvular Mean Pressure Gradient (mPG)	transvalvular mean pressure gradient measured by trans-thoracic echocardiography	at postoperative 1 year
Secondary	Effective Orifice Area (EOA)	effective orifice area measured by trans-thoracic echocardiography	at postoperative 1 year
Secondary	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
Secondary	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
Secondary	Number of Participants With All-cause Mortality	patients who died from any cause	at postoperative 1 year
Secondary	Number of Participants With Cardiac Death	Any death related to cardiac events, including sudden death during follow-up	at postoperative 1 year
Secondary	Number of Participants With Aortic Valve-related Events	valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation	at postoperative 1 year