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CompletedNCT03796442Updated Feb 8, 2023Results posted

Comparison of Two Pericardial Bioprostheses in AVR

An interventional study of AVR with AVALUS and AVR with CEPME in Aortic Valve Disease, sponsored by Seoul National University Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-02-08.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Aortic Valve Disease

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Keywords

  • aortic valve replacement
  • bioprosthesis
03

In context

Aortic Valve Disease

231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.

This study's enrollment of 140 is above the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.

Browse Aortic Valve Disease studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients who are going to undergo aortic valve replacement with bioprosthesis

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    AVALUS group

    patients who will undergo aortic valve replacement with Avalus bioprosthesis

    Device: AVR with AVALUS

  • Active comparator
    CEPME group

    patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

    Device: AVR with CEPME

Interventions

  • DeviceAVR with AVALUS

    aortic valve replacement with AVALUS bioprosthesis

  • DeviceAVR with CEPME

    aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

06

What researchers measure

Primary outcomes

  1. Transvalvular Mean Pressure Gradient (mPG)

    transvalvular mean pressure gradient measured by trans-thoracic echocardiography

    Time frame: at postoperative 1 year

Secondary outcomes

  1. Effective Orifice Area (EOA)

    effective orifice area measured by trans-thoracic echocardiography

    Time frame: at postoperative 1 year

  2. Number of Participants With Op Mortality

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

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

  3. 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

    Time frame: at postoperative 1 year

  4. Number of Participants With All-cause Mortality

    patients who died from any cause

    Time frame: at postoperative 1 year

  5. Number of Participants With Cardiac Death

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

    Time frame: at postoperative 1 year

  6. Number of Participants With Aortic Valve-related Events

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

    Time frame: at postoperative 1 year

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Results

Posted Feb 8, 2023

Participant flow

Participant flow — Overall Study
MilestoneAVALUS GroupCEPME Group
Started7070
Completed6663
Not completed47

Outcome measures

PrimaryTransvalvular Mean Pressure Gradient (mPG)

transvalvular mean pressure gradient measured by trans-thoracic echocardiography

Time frame:
at postoperative 1 year
Reported as:
Mean · mmHg
Transvalvular Mean Pressure Gradient (mPG)
mmHgAVALUS GroupCEPME Group
Transvalvular Mean Pressure Gradient (mPG)14.1 ± 4.313.9 ± 5.1
Statistical analysis
  • AVALUS Group vs CEPME Group · t-test, 1 sided · p = 0.0004
SecondaryEffective Orifice Area (EOA)

effective orifice area measured by trans-thoracic echocardiography

Time frame:
at postoperative 1 year
Reported as:
Mean · cm2
Effective Orifice Area (EOA)
cm2AVALUS GroupCEPME Group
Effective Orifice Area (EOA)1.48 ± 0.391.53 ± 0.38
SecondaryNumber of Participants With Op Mortality

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

Time frame:
at postoperative 30 days or at the time of discharge
Reported as:
Count of participants · Participants
Number of Participants With Op Mortality
ParticipantsAVALUS GroupCEPME Group
Number of Participants With Op Mortality00
SecondaryNumber 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

Time frame:
at postoperative 1 year
Reported as:
Count of participants · Participants
Number of Participants With Op Morbidities
ParticipantsAVALUS GroupCEPME Group
Postoperative atrial fibrillation2124
Respiratory complication67
Acute kidney injury42
Stroke22
Low cardiac output21
Complete atrioventricular block20
Bleeding reoperation11
Mediastinitis00
Infective endocarditis00
No complication3233
SecondaryNumber of Participants With All-cause Mortality

patients who died from any cause

Time frame:
at postoperative 1 year
Reported as:
Count of participants · Participants
Number of Participants With All-cause Mortality
ParticipantsAVALUS GroupCEPME Group
Number of Participants With All-cause Mortality16
SecondaryNumber of Participants With Cardiac Death

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

Time frame:
at postoperative 1 year
Reported as:
Count of participants · Participants
Number of Participants With Cardiac Death
ParticipantsAVALUS GroupCEPME Group
Number of Participants With Cardiac Death12
SecondaryNumber of Participants With Aortic Valve-related Events

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

Time frame:
at postoperative 1 year
Reported as:
Count of participants · Participants
Number of Participants With Aortic Valve-related Events
ParticipantsAVALUS GroupCEPME Group
Number of Participants With Aortic Valve-related Events56

Adverse events

Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AVALUS Group1/70 (1.4%)5/70 (7.1%)0/70 (0%)
CEPME Group6/70 (8.6%)6/70 (8.6%)0/70 (0%)
Most frequent serious events
Most frequent serious events
EventAVALUS GroupCEPME Group
nonstructural valve dysfunctionCardiac disorders1/703/70
cardiac deathsCardiac disorders1/702/70
thromboembolismCardiac disorders0/702/70
prosthetic valve endocarditisCardiac disorders2/701/70
permanent pacemaker implantationCardiac disorders2/700/70
bleeding eventCardiac disorders1/700/70

Baseline characteristics

Age, Continuous
Age, Continuous(years)AVALUS GroupCEPME GroupTotal
Mean71.4 ± 5.574.3 ± 6.972.8 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)AVALUS GroupCEPME GroupTotal
Female363369
Male343771
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AVALUS GroupCEPME GroupTotal
American Indian or Alaska Native000
Asian7070140
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)AVALUS GroupCEPME GroupTotal
South Korea7070140
Body mass index
Body mass index(kg/m^2)AVALUS GroupCEPME GroupTotal
Mean24.8 ± 3.424.4 ± 2.824.6 ± 3.1
Body surface area
Body surface area(m^2)AVALUS GroupCEPME GroupTotal
Mean1.64 ± 0.181.65 ± 0.151.65 ± 0.16
Diabetes mellitus
Diabetes mellitus(Participants)AVALUS GroupCEPME GroupTotal
Count of participants242448
Hypertension
Hypertension(Participants)AVALUS GroupCEPME GroupTotal
Count of participants524799

8 further baseline measures are reported on the registry.

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Study locations

2 sites
  • Seoul National University Bundang Hospital
    Seongnam, Korea, Republic of
  • Seoul National University Hospital
    Seoul, Korea, Republic of
09

References and documents

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. 2023 Dec;71(8):648-655. doi: 10.1055/s-0042-1753494. Epub 2022 Aug 2. PubMed 35917824 ↗

Study documents

  • Study protocol · Dec 28, 2018
  • Statistical analysis plan · Dec 28, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — IPD will not be shared because it is not allowed by our institutional IRB.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03796442
Lead sponsor
Seoul National University Hospital
Collaborators
Seoul National University Bundang Hospital
Responsible party
Ho Young Hwang (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 8, 2019
Start date
Jan 23, 2019
Primary completion
May 13, 2021
Completion
May 31, 2022
Results posted
Feb 8, 2023
Last update
Feb 8, 2023

Study contacts

Ho Young Hwang, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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