Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of Paravalvular Leak (Clinical Trial).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Number of subjects with sizing procedure success (efficacy outcome)
研究概览
简要总结
Paravalvular leak (PVL) is a condition that could be treated surgically or by the transcatheter deployment of the occluder devices (plugs).
No PVL-specific occluder device is available on the market. VALE consortium plans to design and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of computer 3D modeling, bench testing, preclinical evaluation and clinical research.
详细描述
Transcatheter closure of PVL has emerged as a new treatment strategy that can be offered to patients with isolated PVL or to those with a very high risk of repeat surgery. The transcatheter approach involves deployment of occlude devices or coils and adopting either a percutaneous or a transapical approach. Limitation of such approach is the fact that no PVL-dedicated device is available on the market, and either vascular-specific plugs or other types of occluders used commonly for closure of ventricular septal defects or patent ductus arteriosus can be used. Several technical issues can make the procedure challenging.
The primary problem is the localization and track of the canal which can be very difficult to engage and cross with the guidewire. Also the maneuverability of the guide catheter in often enlarged left atrium and the passage of the occluder device through narrow and serpiginous canal between calcified annulus and sewing ring is challenging.
Clearly the limitations of current devices and increasing number of patients with significant PVL warrant the attempts to design and validate new PVL-dedicated devices in the context of computer modeling, bench testing, preclinical evaluation and clinical translation. These devices, as sizing balloon, could significantly simplify and shorten the procedure, decrease the risk of complications and incomplete defect closure as well as optimize cost-effectiveness of the procedure by decreasing number of the occluders.
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
- Device Feasibility
- 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
- •The presence of clinically and haemodynamically significant leakage around the surgically implanted cardiac prosthesis in the mitral or aortic position.
- •Heart surgery (heart team) disability after another cardiac surgery.
- •Technical feasibility of paravalvular leakage closure according to experienced operator.
排除标准
- •Active endocarditis on artificial valve
- •Instability of artificial valve
- •The amount of cavity that prevents effective closure with an occluder
- •A history of acute coronary syndrome in less than 3 months before enrollment
- •Confirmed echocardiography of transplatin or transesophageal echocardiography
- •Hypersensitivity to contrast media
- •Any condition associated with the expected life expectancy of less than 6 months
- •Haemorrhagic diathesis
- •Significant renal impairment (eGFR <30 mL/min/1.73m2)/chronic kidney disease at >G3 stage
- •Pregnancy or lactation
- •Under 18 years of age
- •Patient unable or unwilling to give an informed consent to participate in the study
研究组 & 干预措施
VALE - PVL leak sizing balloon - mitral
Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in mitral position - Balton developed investigational balloon
干预措施: Visualisation and measuring of paravalvular leak. (Device)
VALE - PVL leak sizing balloon - aortic
'Placement and inflation of PVL leak sizing balloon for visualisation and measuring of paravalvular leak located in aortic position - Balton developed investigational balloon
干预措施: Visualisation and measuring of paravalvular leak. (Device)
结局指标
主要结局
Number of subjects with sizing procedure success (efficacy outcome)
时间窗: During index procedure
Sizing procedure is defined as effective when all following steps: device introduction into the leakage channel, filling in the leakage channel, obtaining a balloon image in the X-ray recording and removal of the balloon without complications are performed.
Incidence of a combined investigational device safety endpoint (safety outcome)
时间窗: During index procedure
Safety of the investigational device defined as the occurrence/frequency of locking, fragmentation of the dimensioning balloon, enlargement of the leakage channel, locking of the mechanical prosthesis disks. Failure to use the investigational device defined as: locking of the dimensional balloon in site, fragmentation of the dimensional balloon, enlargement of the leakage channel dimension directly related to the application of the dimensional balloon, locking of the mechanical prosthesis disks. The failure will be assessed per investigational device and accounted for if at least one of four described events occur. Moreover, the frequency of each event will be additionally assessed and presented in per investigational device analysis.
次要结局
- Duration of the dimensional procedure.(During index procedure)
- Frequency and severity of hemorrhagic complications(30 days observation)
- Total radiation dose.(During index procedure)
- Frequency of major undesirable cardiovascular events(30 days observation)
- Total radiation time.(During index procedure)
- Size of paravalvular leakage after procedure(During index procedure)
- Comparison of the size of the paravalvular leakage channel illustrated by a dimensional balloon obtained using 3D-TEE and computerized tomography echocardiography(During index procedure)