NCT02484898已完成不适用
SEEQ™ Performance Study
Medtronic Cardiac Rhythm and Heart Failure0 个研究点目标入组 200 人开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Diagnostic Yield of the SEEQ™ MCT/ECM System
研究概览
简要总结
The purpose of the Medtronic SEEQ™ Performance study is to build further evidence on the clinical and economic benefit of the Medtronic market-released SEEQ™ Mobile Cardiac Telemetry System/External Cardiac Monitor System (MCT/ECM).
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
- •Patient is indicated for a SEEQ™ MCT/ECM System for approved indications
- •Patient is 18 years of age or older
- •Patient is willing and able to provide consent and authorize the use and disclosure of health information
- •Patient is willing and able to comply with the protocol
排除标准
- •Patient has known allergy and/or hypersensitivity to adhesives or hydrogel.
- •Patient has suspected potential life-threatening arrhythmias, or requires in-subject/in-hospital monitoring.
- •Patient will undergo a medical procedure that would preclude full participate during the prescribed duration of the SEEQ™
- •Patient has an implanted cardiac device, (e.g., pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy)
结局指标
主要结局
Diagnostic Yield of the SEEQ™ MCT/ECM System
时间窗: 120 Days
次要结局
未报告次要终点
研究者
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