CTRI/2017/02/007780已完成Unknown
Profiling of Implantable Cardiac Device Diagnostics trends during Clinical Events for co-morbid conditions in Indian Patients
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Correlate the device measured diagnostics parameters to any clinical event in subjects which lead to a major medication change, IV drug therapy, hospitalization, outside home treatment or any similar event. This will help outline the diagnostic changes seen in such subjects prior to acute clinical events.
研究概览
简要总结
| The purpose of this study is to evaluate whether device diagnostics within Medtronic’s ICD, CRT and Pacemaker devices with the Cardiac Compass® and Optivol® feature can identify patients at risk for clinical events leading to hospitalization in Indian patients who are also very prone to co-morbid disease conditions like HF, Atrial fibrilation ,COPD, Diabetes and Renal dysfunction |
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 62.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subject must be greater than 18 years of age.
- •2.Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
- •3.Subjects between 18 years and 62 years of age must have at least 1 clinical event ,such as any major medication change, IV drug therapy, hospitalization, outside home-treatment or any similar event in the past 1 year from the date of enrollment which required a Pharmacologic intervention, associated with any of the following comorbid conditions a) Heart failure b) Chronic Obstructive Pulmonary Disease (COPD) c) Renal deficiency d) Atrial fibrillation e) Diabetes
- •Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
- •If the subject is over 62 years of age then subject can be enrolled in the study without any pre-condition of a clinical event associated with a comorbid condition.
排除标准
- •Subject is unwilling or unable to give informed consent.
结局指标
主要结局
Correlate the device measured diagnostics parameters to any clinical event in subjects which lead to a major medication change, IV drug therapy, hospitalization, outside home treatment or any similar event. This will help outline the diagnostic changes seen in such subjects prior to acute clinical events.
时间窗: Study does not have any follow up visit and only looks retrospective events of patients and this data will be evaluated at the end of six months on the study.
次要结局
未报告次要终点
研究者
研究点 (4)
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