CT-scan Sizing Perceval Sutureless Valve
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge
研究概览
简要总结
The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves .
Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.
详细描述
Recent evidence in TAVI patients suggests that significant underexpansion or distortion of valved stents may be associated with altered leaflet function, leading to increased transprosthetic gradients and possibly predisposing to other negative outcomes such as valve thrombosis, low platelet counts, thromboembolic events, and early degeneration . Moreover, there is evidence that excessive oversizing of the Perceval valve is detrimental.
The present study is aimed to investigate the relationship between the CT-derived measure of the annulus dimension and early hemodynamic and clinical outcomes in patients undergoing sutureless aortic valve replacement (AVR) with the Perceval sutureless aortic valve and define the Perceval sizing chart based on preoperative CT-scan measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female subjects > 18 years;
- •Subjects willing to sign and date an informed consent for treatment of personal data;
- •Subjects willing and able to comply with the follow up schedule of the protocol;
- •Subjects with indication for aortic valve replacement on a tricuspid aortic valve;
- •Subjects with possibly associated need for coronary revascularization.
- •Subjects with Ejection Fraction ≥ 40%
排除标准
- •Male and female subjects ≤ 18 years;
- •Subjects with bicuspid aortic valve
- •Subjects with associated mitral valvulopathy or ascending aorta aneurysm
- •Subjects with pure aortic insufficiency
- •Subjects with Ejection Fraction < 40%
- •Subjects with acute myocardial infarction < 30 gg
- •Subjects with serum creatinine > 2 mg/Dl
结局指标
主要结局
Evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge
时间窗: 12 months
The primary endpoint is to evaluate the proper Perceval valve size assessed by the early postoperative outcomes at discharge in terms of: * Mean and peak pressure gradients * Prosthetic regurgitation * migration/dislodgement * need for permanent pacemaker implant
次要结局
未报告次要终点