NL-OMON33875已完成2 期
Place of Reveal® In the peri-operative aSsessment of patients undergoing Major vascular surgery (PRISM2). - PRISM2
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patient is scheduled for non-cardiac vascular surgery of the for elective aortic abdominal aneurysm repair or lower extremity bypass surgery;
- •Patients eligible for the study are 18 years or older;
- •Patient is willing to receive a Reveal XT insertion and can be implanted with Reveal XT;
- •Patient is willing to wear external Holter devices for a 72 hour period;
- •Patient is willing to give his/her informed consent;
排除标准
- •Patient has an implanted pacemaker or ICD;
- •Patient has an allergy against adhesive surface ECG electrode;
- •The study will interfere with a therapeutic or diagnostic procedure which is planned or expected within the study period;
- •Patient is a minor, legally incompetent, or does not meet other local requirements for participation in a clinical study.
- •Patients has electrocardiographic abnormalities that preclude assessment of cardiac arrhythmias or myocardial ischemia will be excluded.
- •Patient has a changing ST-segment, i.e. a Bundle Branch Block and further ST-segment changes cannot be assessed.
- •Patient is pregnant
研究者
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