NCT06910059进行中（未招募）不适用
The CT-verified Data Collection Study to Investigate the Correlation Between the Leadless Pacemaker Tip Location and Echo, ECG
Medtronic Cardiac Rhythm and Heart Failure2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年6月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assessment of ECG characteristics in relation to Micra tip location
研究概览
简要总结
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location.
The secondary objective is (1) to identify an optimal Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and tricuspid regurgitation, and (3) to investigate whether Micra location would impact AV synchrony. Patients with pacing indications who plan to receive Micra AV implantation will be recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients aged above 18 years old
- •Patients who are willing to provide Informed Consent
- •Patients with Class I or II indications who plan to receive a leadless pacemaker, including SSS, AVB, AF with bradycardia, etc.
- •Patients who plan to conduct a cardiac CT scan after implantation
排除标准
- •Patients with lead retention
- •Patients had heart valve replacement
- •Patients diagnosed with ischemic heart diseases
- •Patients who are allergic to or refuse to use contrast in CT scans
- •Patients who are pregnant or have a plan for pregnancy during the study
- •Patients with medical conditions that would limit study participation
- •Patients already enrolled in another clinical trial which would impact participation of this study
结局指标
主要结局
Assessment of ECG characteristics in relation to Micra tip location
时间窗: Within 6 months after the surgery.
Patients' ECG will be measured to see whether there is difference in ECG characteristics between Micra tip locations.
次要结局
- Cardiac functional changes(Within 6 months after the surgery.)
- To investigate whether Micra location would impact AV synchrony(Within 6 months after the surgery.)
研究者
研究点 (2)
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