NCT05440071尚未招募不适用
PoSt-market Assessment on Safety and Performance of J-sHAPed xFINE Lead
MicroPort CRM0 个研究点目标入组 129 人开始时间: 2022年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 129
- 主要终点
- Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
研究概览
简要总结
The primary objective of this study is to evaluate the safety and the electrical performances of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
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
- •Subject has reviewed, signed and dated the informed consent form
- •Subject newly implanted (de novo) with a JX XFINE within 10 days, connected to a dual chamber (DR) pacemaker from MicroPort CRM S.r.l and any commercially available IS-1 right ventricular lead
- •Subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol.
排除标准
- •Subjects with documented permanent or persistent AF
- •Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device
- •Subject has had any pacing or ICD system implants
- •Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
- •Age less than 18 years old, incapacitated or under guardianship or kept in detention
- •Life expectancy less than 1 year
结局指标
主要结局
Safety of the right atrial J-shape (JX model) XFINE endovascular passive lead at 3 months post implant.
时间窗: 3 months
Electrical performances of the right atrial J-shape (JX model) XFINE endovascular at 3 months
时间窗: 3 months
次要结局
未报告次要终点
研究者
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