CTRI/2017/02/007780
已完成
4 期
Profiling of Implantable Cardiac Device Diagnostics trends during Clinical Events for co-morbid conditions in Indian Patients - PATTERNS
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Health Condition 1: null- All subjects implanted with Medtronic Cardiac devices with the Cardiac Compass® and OptiVol® feature can be evaluated for the study.
- 发起方
- Medtronic Inc
- 入组人数
- 200
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
暂无简介。
研究者
入排标准
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
- •4\. Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
- •5\. 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
未指定
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