Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure -the 3DP-FAST Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Rate of complications during 12 months follow-up of patients undergoing TAVI for aortic stenosis
研究概览
简要总结
• The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI procedure. By conducting a comparative analysis of measurements achieved on CCTA images versus measurements obtained with a specialized projection platform by photogrammetry vs 3D printed models of various aortic valvular and perivalvular structures will be evaluated the accuracy of each step of image dataset processing. Furthermore, the study will evaluate the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block based on coronary computed tomography angiographic and ECG assessment at 1 year after enrollment.
详细描述
The project is a prospective, cohort, mono-centric study which will be carried out in CardioMed Medical Center in collaboration with the University of Medicine, Pharmacy, Science and Technology "George Emil Palade" of Târgu Mureș.
The project will include 20 subjects who present severe aortic stenosis prior to study enrollment.
Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVI by the Center of Advanced Research in Multimodal Cardiac Imaging Cardiomed Heart Valve Team.
All patients will undergo coronary CT angiography, cardiac perfusion CT and peripheral CT angiography at the moment of enrollment in the study, for complex assessment of aortic valvular and perivalvular structures as well as for peripheral vascular approach.
The study will be conducted over a period of 1 year, in which patients will be examined at baseline, and during follow-up visit. At the one-year follow-up, the study subjects will undergo CT coronary angiography for re-evaluation of the aortic valve, in the prospects of analyzing the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block. In case of non-presentation for the follow-up visit, patients will be contacted via telephone by one of the investigators, and questioned about the general health status, occurrence of cardiovascular or cerebrovascular symptoms and interventions, for possible non-cardiovascular related hospitalizations, as well as regarding the presence of aortic valvular disease rates/repeated interventions.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with degenerative aortic stenosis who present the criteria for transcatheter aortic valve intervention, who undergo coronary CCTA and CT angiography of the abdominal aorta and lower limbs.
排除标准
- •contraindications for TAVI procedures
- •patients that undergo surgical aortic valve replacement for aortic stenosis
- •patients with contraindications for iodine contrast agent administration (acute renal failure, allergy, thyroid dysfunction).
- •other conditions associated with suboptimal CCTA image acquisition which could interfere with CT image postprocessing for creation of 3D printed models.
结局指标
主要结局
Rate of complications during 12 months follow-up of patients undergoing TAVI for aortic stenosis
时间窗: 12 months
Re-evaluation of the aortic valve, in the prospects of analyzing the rate of valvular leak or peri-procedural complications such as embolic events or atrio-ventricular conduction block during a 12 months follow-up after TAVI procedure.
Feasibility of 3D printed models of aortic valves in guiding TAVI procedure
时间窗: at baseline
Analysis of the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI procedure.
次要结局
未报告次要终点