Addition of Computer Simulations to the Pre-procedural Planning to Minimize Adverse Events After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- overall device success conform the VARC-2 document
研究概览
简要总结
The objective is to assess the influence of FEops HEARTguide on overall device success in TAVI patients with challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
详细描述
Rationale Transcatheter aortic valve implantation (TAVI) is increasingly used to treat patients with severe aortic stenosis. However, by extending the indication for TAVI, simulation may become increasingly important to improve procedure execution, safety and efficacy.
Objective Assess the influence of FEops HEARTguideTM on overall device success in challenging anatomies (Cohort A) or in transcatheter heart valve (THV) platform selection (Cohort B).
Study design Prospective, observational multi-center trial with 2 cohorts.
Study population
- Cohort A: patients with challenging anatomy undergoing EvolutTM TAVI (Medtronic, Minneapolis, Minnesota), to evaluate the influence of FEops HeartGuideTM on overall device success through valve size and implantation depth.
- Cohort B: consecutive patients, eligible for TAVI with ACURATE NEO2 TM (Boston Scientific, Marlborough, Massachusetts) to evaluate the influence of FEops heartGuideTM on overall device success and PVL prediction.
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
- •Cohort A:
- •Patients with a Bicuspid Aortic Valve (Sievers 0 or 1) or functional Bicuspid Aortic Valve
- •Patients with a severely calcified aortic valve (Agatston score > 3000 for men, and > 1600 for women)
- •Patients with small anatomy defined by mean aortic annulus diameter < 20mm
- •Cohort B:
- •every patient accepted for TAVI and eligible for ACURATE-NEO2-valve.
排除标准
- •poor CT quality
- •previous aortic valve replacement
- •Permanent pacemaker at baseline
结局指标
主要结局
overall device success conform the VARC-2 document
时间窗: 30 days after TAVI
* Incidence of mortality * incidence of stroke * incidence of major vascular complication * incidence of life-threatening bleeding
次要结局
- incidence of more than trivial PVL(30 days after TAVI)
- conduction abnormalities and need for new permanent pacemaker implantation(30 days after TAVI)
研究者
Nicolas van Mieghem
principal investigator
Erasmus Medical Center