NCT05788770招募中不适用
Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial
Romy Hegeman3 个研究点 分布在 2 个国家目标入组 454 人开始时间: 2022年4月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 454
- 试验地点
- 3
- 主要终点
- Mild to severe paravalvular regurgitation
研究概览
简要总结
Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders.
The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Primary symptomatic severe aortic valve stenosis
- •Accepted for TAVR, either by transfemoral, transsubclavian or transapical access
- •Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA)
- •Informed consent
排除标准
- •a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:
- •Previous surgical aortic valve replacement
- •Permanent pacemaker at baseline
- •Emergency procedure
- •Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest
- •Patient who did not agree to the informed consent and/or refused to participate
- •Patient unable to understand the informed consent/study
结局指标
主要结局
Mild to severe paravalvular regurgitation
时间窗: 30-days
次要结局
- Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)(30 days after TAVI)
- Need for permanent pacemaker implantation(30 days after TAVI)
- Preoperative valve size selection(Preprocedural)
- Final valve size(Perprocedural)
- Target implantation depth(Preprocedural)
- Final implantation depth(Perprocedural)
- Change of preoperative decision in choice of default transcather heart valve(Preprocedural)
- Change of preoperative decision in valve size selection(Preprocedural)
- Change of preoperative decision in target implantation depth(Preprocedural)
- Failure to implant valve(Preprocedural)
- Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire(90 days after TAVI)
- Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)(30 days after TAVI)
- Quality of life assessed by the EuroQol questionnaire(90 days after TAVI)
研究者
Romy Hegeman
MD
St. Antonius Hospital
研究点 (3)
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