NCT02191696已完成不适用
Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- IMED-4 recordings
研究概览
简要总结
The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4
详细描述
The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.
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
- •Subjects with an active implantable CRM device
- •Subjects > 18 years of age
- •Subjects who are ambulatory not requiring assistance for ambulation
- •Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB
排除标准
- •Subjects who are pregnant or lactating or who have been pregnant within the past three months
- •Subjects who have tattoos on the back in the electrode patch placement region
- •Subjects who have had a past allergic reaction to adhesives
- •Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
结局指标
主要结局
IMED-4 recordings
时间窗: 6 months
The primary endpoint is a collection of CRM device programmer printouts containing real-time lead sensing data from up to 40 unique subjects.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
终止
4 期
Clinical Status Monitoring in Implantable Cardiac Defibrillator (ICD) Patients by Physiological Diagnosis (PhD) FunctionHeart FailureNCT01170624LivaNova388
已完成
不适用
Evaluation of CIED "Readers" for Disease ManagementPacemaker DddICDNCT03338946Edward Hospital100
招募中
不适用
Yield of Implantable Cardiac Monitoring Device in Patients With Acute Ischemic Stroke.Stroke, AcuteStroke, IschemicStrokeAtrial FibrillationNCT05494034National and Kapodistrian University of Athens200
已完成
不适用
Study of the Implantable Cardioverter Defibrillator (ICD) Intracardiac ElectrogramsCardiomyopathiesCongestive Heart FailureSudden Cardiac DeathArrhythmiaNCT00916435Johns Hopkins University630
Unknown
不适用
External Sensors for remoTe MoniToring of Heart Failure Patients With Implantable DefibrillatorsCongestive Heart FailureNCT02147340Maurizio Eugenio Landolina186