NCT05492383已完成不适用
SAvvyWire™ EFficacy and SafEty in Transcatheter Aortic Valve Implantation Procedures (SAFE-TAVI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Opsens, Inc.
- 入组人数
- 119
- 试验地点
- 12
- 主要终点
- Percentage of patients with effective rapid pacing run
研究概览
简要总结
The purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of SavvyWire™ during TAVI procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Investigation participant number only
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
- •Subject is at least 18 years old
- •Subject has a severe symptomatic AS undergoing a TAVI procedure
- •Subject with a THV for which rapid pacing is considered necessary during valve implantation
- •Subject agrees to participate in the study and is able to sign the informed consent form
排除标准
- •Failure to provide signed informed consent
- •Extremely horizontal aorta (aortic root angle ≥70°)
- •Extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta
- •Inability to receive full anticoagulation during the TAVI procedure
- •Prohibitive surgical risk precluding (according to the Heart Team) conversion to open heart surgery in case of a life-threatening complication.
结局指标
主要结局
Percentage of patients with effective rapid pacing run
时间窗: during surgery
Effective rapid pacing will be defined as an adequate ventricular pacing capture by the SavvyWireTM leading to a reduction of systolic aortic pressure value \<60 mmHg.
次要结局
- Percentage of patients with hemodynamic assessment without additional manipulation (pressure efficacy)(during surgery)
- Percentage of patient with valve advancement to intended position (mechanical efficacy)(during surgery)
- Presence of major complications (safety)(during surgery)
研究者
研究点 (12)
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