Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comparison of maximum and minimum velocity under patient specific conditions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
"Sutureless" valve
Patients who underwent aortic valve replacement with a "sutureless" aortic valve.
An echocardiogram and a cardiac CT-scan will be conducted.
干预措施: Cardiac CT-scan (Radiation)
"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.
干预措施: Cardiac CT-scan (Radiation)
结局指标
主要结局
Comparison of maximum and minimum velocity under patient specific conditions
时间窗: between 6 months and 4 years after aortic valve replacement
Comparison of the effective orifice area under patient specific conditions
时间窗: between 6 months and 4 years after aortic valve replacement
Comparison of the percentage of turbulent flow under patient specific conditions
时间窗: between 6 months and 4 years after aortic valve replacement
Comparison of the pressure drop under patient specific conditions
时间窗: between 6 months and 4 years after aortic valve replacement
次要结局
- Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.(between 6 months and 4 years after aortic valve replacement)
- Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.(between 6 months and 4 years after aortic valve replacement)
研究者
Alfred A Kocher, MD
Professor
Medical University of Vienna