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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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.
研究者
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