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Completed

NCT Number: NCT03796442

Comparison of Two Pericardial Bioprostheses in AVR

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital, Seongnam, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVR with AVALUS

Device

aortic valve replacement with AVALUS bioprosthesis

AVR with CEPME

Device

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Primary outcomes

  1. Transvalvular Mean Pressure Gradient (mPG)

    Time frame: at postoperative 1 year

    transvalvular mean pressure gradient measured by trans-thoracic echocardiography

Secondary outcomes

  1. Effective Orifice Area (EOA)

    Time frame: at postoperative 1 year

    effective orifice area measured by trans-thoracic echocardiography

  2. Number of Participants With Op Mortality

    Time frame: at postoperative 30 days or at the time of discharge

    any death within 30 days after surgery or during the same hospital admission

  3. Number of Participants With Op Morbidities

    Time frame: 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

  4. Number of Participants With All-cause Mortality

    Time frame: at postoperative 1 year

    patients who died from any cause

  5. Number of Participants With Cardiac Death

    Time frame: at postoperative 1 year

    Any death related to cardiac events, including sudden death during follow-up

  6. Number of Participants With Aortic Valve-related Events

    Time frame: at postoperative 1 year

    valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 8, 2019
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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