Aortic Valve DiseaseNCT03796442
Comparison of Two Pericardial Bioprostheses in AVR
A study testing AVR with AVALUS and AVR with CEPME in people with Aortic Valve Disease, run by Seoul National University Hospital at 2 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- AVR with AVALUS and AVR with CEPME
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 23 Jan 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are going to undergo aortic valve replacement with bioprosthesis
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam
Seoul National University Hospital
Seoul
About this study
Official title: Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial
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.
- Conditions
- Aortic Valve Disease
- Being tested
- AVR with AVALUS, AVR with CEPME
- Keywords
- aortic valve replacement, bioprosthesis
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVR with AVALUSDevice
aortic valve replacement with AVALUS bioprosthesis
AVR with CEPMEDevice
aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
| Study group | Role | What they receive |
|---|---|---|
| AVALUS group | Experimental | patients who will undergo aortic valve replacement with Avalus bioprosthesis Receives: Device: AVR with AVALUS |
| CEPME group | Active comparator | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis Receives: Device: AVR with CEPME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transvalvular Mean Pressure Gradient (mPG)
transvalvular mean pressure gradient measured by trans-thoracic echocardiography
Measured: at postoperative 1 year
Secondary outcomes (6)
Effective Orifice Area (EOA)
effective orifice area measured by trans-thoracic echocardiography
Measured: at postoperative 1 year
Number of Participants With Op Mortality
any death within 30 days after surgery or during the same hospital admission
Measured: at postoperative 30 days or at the time of discharge
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
Measured: at postoperative 1 year
Number of Participants With All-cause Mortality
patients who died from any cause
Measured: at postoperative 1 year
Number of Participants With Cardiac Death
Any death related to cardiac events, including sudden death during follow-up
Measured: at postoperative 1 year
Number of Participants With Aortic Valve-related Events
valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation
Measured: at postoperative 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start23 Jan 2019
- Primary completion13 May 2021
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Ho Young Hwang, Seoul National University Hospital
- Investigators
- Ho Young Hwang, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796442
- Sponsor's protocol ID
- D-1812-024-991
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2019
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared because it is not allowed by our institutional IRB.
Publications
Sohn SH, Kang Y, Kim JS, Choi JW, Lee JH, Kim JS, Lim C, Hwang HY. A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2025 Mar;73(2):132-140. doi: 10.1055/a-2199-2087. Epub 2023 Oct 26.
PubMed 37884030Sohn 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 at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and 1-year Hemodynamic Performance and Clinical Outcomes After Aortic Valve Replacement Using Two Pericardial Bioprostheses: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03796442
- Acronym / sponsor ID
- D-1812-024-991
- Conditions
- Aortic Valve Disease
- Keywords
- aortic valve replacement, bioprosthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 8 Jan 2019 (actual)
- Results
- Posted 8 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AVALUS group | Experimental | Device: AVR with AVALUSpatients who will undergo aortic valve replacement with Avalus bioprosthesis |
| CEPME group | Active comparator | Device: AVR with CEPMEpatients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who are going to undergo aortic valve replacement with bioprosthesis
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVR with AVALUSaortic valve replacement with AVALUS bioprosthesis | Device | AVALUS group |
| AVR with CEPMEaortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis | Device | CEPME group |
Primary outcome
Transvalvular Mean Pressure Gradient (mPG)
Time frame: at postoperative 1 year
transvalvular mean pressure gradient measured by trans-thoracic echocardiography
6 secondary outcomes
Effective Orifice Area (EOA)
Time frame: at postoperative 1 year
Number of Participants With Op Mortality
Time frame: at postoperative 30 days or at the time of discharge
Number of Participants With Op Morbidities
Time frame: at postoperative 1 year
Number of Participants With All-cause Mortality
Time frame: at postoperative 1 year
Number of Participants With Cardiac Death
Time frame: at postoperative 1 year
Number of Participants With Aortic Valve-related Events
Time frame: at postoperative 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37884030Sohn SH, Kang Y, Kim JS, Choi JW, Lee JH, Kim JS, Lim C, Hwang HY. A Controlled Trial Comparing One-Year Hemodynamics of Two Bovine Pericardial Valves. Thorac Cardiovasc Surg. 2025 Mar;73(2):132-140. doi: 10.1055/a-2199-2087. Epub 2023 Oct 26.
- Derived from this study: PubMed 35917824Sohn 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.
- Individual participant dataSharing planned: No. IPD will not be shared because it is not allowed by our institutional IRB.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ho Young Hwang, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVR with AVALUS and AVR with CEPME in people with Aortic Valve Disease, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transvalvular Mean Pressure Gradient (mPG) (time frame: at postoperative 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03796442, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.