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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVALUS group | Experimental | patients who will undergo aortic valve replacement with Avalus bioprosthesis |
|
| CEPME group | Active Comparator | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVR with AVALUS | Device | aortic valve replacement with AVALUS bioprosthesis |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Transvalvular Mean Pressure Gradient (mPG) | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | at postoperative 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Effective Orifice Area (EOA) | effective orifice area measured by trans-thoracic echocardiography | at postoperative 1 year |
| Number of Participants With Op Mortality | any death within 30 days after surgery or during the same hospital admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ho Young Hwang, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam | South Korea | ||||
| Seoul National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37884030 | Derived | 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. | |
| 35917824 | Derived | 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. |
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IPD will not be shared because it is not allowed by our institutional IRB.
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| ID | Title | Description |
|---|---|---|
| FG000 | AVALUS Group | patients who will undergo aortic valve replacement with Avalus bioprosthesis AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
| FG001 | CEPME Group | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AVALUS Group | patients who will undergo aortic valve replacement with Avalus bioprosthesis AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
| BG001 | CEPME Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Transvalvular Mean Pressure Gradient (mPG) | transvalvular mean pressure gradient measured by trans-thoracic echocardiography | Posted | Mean | Standard Deviation | mmHg | at postoperative 1 year |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AVALUS Group | patients who will undergo aortic valve replacement with Avalus bioprosthesis AVR with AVALUS: aortic valve replacement with AVALUS bioprosthesis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cardiac deaths | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ho Young Hwang | Seoul National University Hospital | 00-82-2-2072-3020 | scalpel@snu.ac.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 28, 2018 | Oct 30, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 28, 2018 | Oct 30, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| AVR with CEPME |
| Device |
aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis |
|
| 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 | at postoperative 1 year |
| Number of Participants With All-cause Mortality | patients who died from any cause | at postoperative 1 year |
| Number of Participants With Cardiac Death | Any death related to cardiac events, including sudden death during follow-up | at postoperative 1 year |
| Number of Participants With Aortic Valve-related Events | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation | at postoperative 1 year |
| Seoul |
| South Korea |
patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Body surface area | Mean | Standard Deviation | m^2 |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Dyslipidemia | Count of Participants | Participants |
|
| Chronic obstructive pulmonary disease | Count of Participants | Participants |
|
| Stroke | Count of Participants | Participants |
|
| Chronic kidney disease | Count of Participants | Participants |
|
| Peripheral vascular disease | Count of Participants | Participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
| Reoperation | Count of Participants | Participants |
|
| EuroSCORE II | The EuroSCORE II (European System for Cardiac Operative Risk Evaluation) is a prognostic scoring system developed in Europe for patients undergoing cardiac surgery. It calculates the risk of in-hospital mortality after major cardiac surgery. The scale ranges from 0 to 100. Higher value of the EuroSCORE II represents that the patient is predicted to have a worse outcome. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Effective Orifice Area (EOA) | effective orifice area measured by trans-thoracic echocardiography | Posted | Mean | Standard Deviation | cm2 | at postoperative 1 year |
|
|
|
| Secondary | Number of Participants With Op Mortality | any death within 30 days after surgery or during the same hospital admission | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | at postoperative 1 year |
|
|
|
| Secondary | Number of Participants With All-cause Mortality | patients who died from any cause | Posted | Count of Participants | Participants | at postoperative 1 year |
|
|
|
| Secondary | Number of Participants With Cardiac Death | Any death related to cardiac events, including sudden death during follow-up | Posted | Count of Participants | Participants | at postoperative 1 year |
|
|
|
| Secondary | Number of Participants With Aortic Valve-related Events | valve-related mortality, thromboembolism, bleeding, endocarditis, reoperation | Posted | Count of Participants | Participants | at postoperative 1 year |
|
|
|
| 1 |
| 70 |
| 5 |
| 70 |
| 0 |
| 70 |
| EG001 | CEPME Group | patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis AVR with CEPME: aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis | 6 | 70 | 6 | 70 | 0 | 70 |
| nonstructural valve dysfunction | Cardiac disorders | Systematic Assessment |
|
| thromboembolism | Cardiac disorders | Systematic Assessment |
|
| bleeding event | Cardiac disorders | Systematic Assessment |
|
| prosthetic valve endocarditis | Cardiac disorders | Systematic Assessment |
|
| permanent pacemaker implantation | Cardiac disorders | Systematic Assessment |
|
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| Acute kidney injury |
|
| Stroke |
|
| Low cardiac output |
|
| Complete atrioventricular block |
|
| Bleeding reoperation |
|
| Mediastinitis |
|
| Infective endocarditis |
|
| No complication |
|