跳至主要内容
临床试验/CTRI/2017/02/007780
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

Medtronic Inc0 个研究点目标入组 200 人待定

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。

注册库
who.int
开始日期
待定
结束日期
2018年1月30日
最后更新
4年前
研究类型
Observational

研究者

发起方
Medtronic Inc

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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