Clinical trial NCT03796442: 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
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: aortic valve replacement
bioprosthesis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2019-01-08
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Transvalvular Mean Pressure Gradient (mPG)
timeFrame: at postoperative 1 year
Secondary outcomes:
measure: Effective Orifice Area (EOA)
timeFrame: at postoperative 1 year
measure: Number of Participants With Op Mortality
timeFrame: at postoperative 30 days or at the time of discharge
measure: Number of Participants With Op Morbidities
timeFrame: at postoperative 1 year
measure: Number of Participants With All-cause Mortality
timeFrame: at postoperative 1 year
measure: Number of Participants With Cardiac Death
timeFrame: at postoperative 1 year
measure: Number of Participants With Aortic Valve-related Events
timeFrame: at postoperative 1 year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Ho Young Hwang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. 2023 Dec;71(8):648-655. doi: 10.1055/s-0042-1753494. Epub 2022 Aug 2.