NL-OMON49111撤回2 期
TriGUARD 3 TransCranial Doppler (TCD) Ultrasound Study: A prospective, randomized, real-time evaluation of blood filtration with the TriGUARD 3 Embolic Protection Device Using TCD During Transcatheter Aortic Valve Implantation (TAVI). - Triguard 3 - TCD study
Keystone Heart0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 30
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
- 18 至 99（—）
入选标准
- •1. The patient must be * 18 years of age.
- •2. The patient meets indications for TAVI procedure.
- •3. The patient has been informed of the nature of the study, agrees to its
- •provisions and has been provided written informed consent, approved by the
- •appropriate Medical Ethics Committee (EC)
- •4. The patient is willing to comply with specified follow-up evaluations.
排除标准
- •1.Patients undergoing TAVI via the trans-axillary, transapical, subclavian, or
- •direct aortic route
- •2 Patients with impaired renal function (estimated Glomerular Filtration Rate
- •[eGFR] <30, calculated from serum creatinine by the Cockcroft-Gault formula).
- •3.Patients with a history of a stroke or transient ischemic attack (TIA) within
- •the prior 6 months.
- •4.Patients with severe peripheral arterial disease that precludes the delivery
- •sheath vascular access.
- •5.Patients who have a planned treatment with any other investigational device
- •or procedure during the study period.
- •6.Patients planned to undergo any other cardiac surgical or interventional
- •procedure during the TAVI procedure (e.g., concurrent coronary
- •revascularization or within 10 days prior to the TAVI procedure. NOTE:
- •Diagnostic cardiac catheterization is permitted within 10 days prior to the
- •TAVI procedure.
- •7 Patients who have closed temporal window(s).
- •8. Patients with scheduled valve-in-valve procedure
研究者
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