Pilot Trial: Comparison of Flow Patterns
Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Vienna、奥地利、1090
- 招聘中
- Medical University of Vienna
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接触：
- Claus Rath, MD
- 电话号码：0043-1-40400-69660
- 邮箱：claus.rath@meduniwien.ac.at
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接触：
- Alfred Kocher, MD
- 电话号码：0043-1-40400-69660
- 邮箱：alfred.kocher@meduniwien.ac.at
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首席研究员：
- Alfred Kocher, MD
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副研究员：
- Claus Rath, MD
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副研究员：
- Martin Andreas, MD
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副研究员：
- Dominik Wiedemann, MD
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副研究员：
- Guenther Laufer, MD
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副研究员：
- Christian Loewe, MD
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副研究员：
- Raphael Rosenhek, MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
- Implanted valve size 23mm
- Surgical access via full sternotomy or hemisternotomy
- Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
- Post-operative ejection fraction ≥50%
- Sinus-Rhythm
- Ability to understand and comply with study procedures
- Signed informed consent
Exclusion Criteria:
- Under 18 years of age
- Emergency surgery
- Pregnancy
- Previous aortic root replacement
- Previous aortic valve replacement
- Previous or concomitant root enlargement
- Previous or concomitant repair of the ascending aorta
- Paravalvular leakage
- Ectasia of the ascending aorta
- Previous or concomitant myomectomy
- Concomitant replacement or repair of valves other than aortic
- Usage of more than 3 sutures for implantation of the Intuity Valve System
- Heavily calcified aortic root
- Glomerular filtration rate (GFR) < 30 ml/min
- Inability to understand or comply with study procedures
- Known allergic reaction to iodinated, non-ionic contrast agents
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他："Sutureless" valve
Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves. |
|
其他："Sewed-in" valve
Patients who underwent aortic valve replacement with a "sewed-in" aortic valve.
An echocardiogram and a cardiac CT-scan will be conducted.
|
ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Comparison of maximum and minimum velocity under patient specific conditions
大体时间：between 6 months and 4 years after aortic valve replacement
|
between 6 months and 4 years after aortic valve replacement
|
|
Comparison of the effective orifice area under patient specific conditions
大体时间：between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
|
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Comparison of the percentage of turbulent flow under patient specific conditions
大体时间：between 6 months and 4 years after aortic valve replacement
|
between 6 months and 4 years after aortic valve replacement
|
|
Comparison of the pressure drop under patient specific conditions
大体时间：between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
大体时间：between 6 months and 4 years after aortic valve replacement
|
The first secondary outcome measure is the comparison of -pressure gradients as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified. If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics." |
between 6 months and 4 years after aortic valve replacement
|
|
Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
大体时间：between 6 months and 4 years after aortic valve replacement
|
The second secondary outcome measure is the comparison of -peak velocity as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified. If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics." |
between 6 months and 4 years after aortic valve replacement
|
合作者和调查者
调查人员
- 首席研究员：Alfred Kocher, MD、Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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