NCT03941275已完成不适用
SelectSecure 3830 Lead Imaging
Medtronic Cardiac Rhythm and Heart Failure4 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2019年5月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
研究概览
简要总结
This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 who are at least 18 years of age
- •Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
- •Patients able and willing to attend imaging session
- •Patients able and willing to give informed consent
- •Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
- •Patient must be able to accomplish arm flexion and adduction past 90 degrees
排除标准
- •Subjects who require a legally authorized representative to obtain consent
- •Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
- •Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
- •Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago
结局指标
主要结局
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
时间窗: approximately 30 minutes
Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.
次要结局
- Acquire accelerometer-based motion data(approximately 30 minutes)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
不适用
Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy: feasibility in a multicentre settingNL-OMON23393niversity Medical Center Utrecht30
招募中
不适用
Advanced Image Supported Lead Placement in Cardiac Resynchronization TherapyChronic heart failure with a reduced ejection fraction and dyssynchronyNL-OMON29327niversity Medical Center Utrecht130
Unknown
不适用
Intraoperative Berger Space Imaging (IBSI)Macula EdemaCataractNCT04775849Medical University of Vienna80
已完成
不适用
Shoulder Motion Guided Patient Diagnostic and Treatment ClassificationRotator Cuff Shoulder Syndrome and Allied DisordersNCT02104531University of Minnesota50
终止
早期 1 期
64Cu-LLP2A for Imaging Multiple MyelomaMultiple MyelomaNCT03804424Washington University School of Medicine10