JPRN-UMIN000051896招募中Unknown
Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX - Clinical Trial to Evaluate the Efficacy and Safety of an Algorithm to Determine the Optimal Valve Placement Position during Transcatheter Aortic Valve Implantation Using the Self-Expanding Valve Evolut FX
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Study subjects with low quality of preoperative CT 2)Prior pacemaker or ICD implantation 3)Prior prosthetic valve implantation in the aortic position 4)Patients with bicuspid aortic valve 5)Contraindications for implantation of bioprosthetic valves 6)Patients with allergy, hypersensitivity or contraindication to any of the following Aspirin or heparin, Ticlopidine and clopidogrel, Nitinol (titanium or nickel), Contrast medium 7)Patients with preoperative renal impairment (eGFR <30 ml/min/1.73m2), or patients on chronic dialysis 8)Patients with left ventricular ejection fraction <30% as measured by preoperative transthoracic cardiac ultrasound. 9)Patients with NYHA IV decompensated heart failure 10)Patients receiving hemodynamic support with circulatory assist devices for cardiogenic shock 11)Persistent sepsis, including active endocarditis 12)Patients with left ventricular thrombus 13)Anatomically unsuitable for TAVI via the femoral approach 14)Patients for whom surgical valvular surgery is indicated by the Heart Team 15)Having any of the following hematologic disorders: leukopenia (white blood cell count < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3). 16)Patients who are pregnant or breastfeeding 17)Currently participating in other clinical trials (excluding registry studies) of investigational drugs or other devices 18)Severe dementia (leading to an inability to receive an explanation for consent for the procedure or difficulty in a follow-up visit after the procedure) 19)Life expectancy is less than 12 months due to non-cardiac comorbidities 20)Patients who have difficulty agreeing on their own will due to cognitive decline 21)Other patients considered by the Principal Investigator to be inappropriate as study subjects
研究者
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