NCT04545619已完成不适用
Acute Performance Evaluation of the QDOT Micro™ Catheter Used With nGEN Generator in Treatment of Patients With Atrial Fibrillation.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of Participants Who Achieved Acute Procedural Success
研究概览
简要总结
This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.
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
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
- •Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation.
- •Age 18 or older.
- •Signed the Patient Informed Consent Form (ICF).
排除标准
- •If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks.
- •Presence of a myxoma or an intracardiac thrombus.
- •Presence of prosthetic valves.
- •Presence of active systemic infection
- •Patient with an interatrial baffle or patch
- •Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
结局指标
主要结局
Number of Participants Who Achieved Acute Procedural Success
时间窗: Up to 104 days
Number of participants who achieved acute procedural success were reported. Acute procedural success was defined as confirmation of entrance block in all targeted pulmonary veins (PVs) after administration of adenosine/isoproterenol using the nGEN / QDOT Micro Ablation System. The participants without any QMODE+ applications for PVI were considered as a failure.
次要结局
- Number of Participants With Adverse Events (AEs)(Up to 104 days)
研究者
研究点 (2)
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