A Prospective Observational Registry Study to Characterise Normal Conditions of Use, Dosing and Safety Following Administration of Vernakalant IV Sterile Concentrate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,015
- 试验地点
- 5
- 主要终点
- Number of Participants Experiencing Significant Hypotension
研究概览
简要总结
This non-interventional prospective study is a post-authorization safety study (PASS) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be treated with intravenous vernakalant, independently of this study
- •Participant and/or legal guardians willing to provide informed consent and/or informed assent according to local regulations
排除标准
- •Enrollment in an investigational drug or device clinical trial in the 30 days prior to study enrolment. Participation in another non-interventional drug or device study or registry is permitted.
研究组 & 干预措施
All participants
Participants treated with vernakalant IV in acute care and inpatient hospital settings
干预措施: Vernakalant (Drug)
结局指标
主要结局
Number of Participants Experiencing Significant Hypotension
时间窗: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Significant hypotension is defined as: symptomatic hypotension with systolic blood pressure (BP) \<90 mmHg, requiring treatment with vasopressors
Number of Participants Experiencing Significant Bradycardia
时间窗: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Ventricular Arrhythmia
时间窗: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
Number of Participants Experiencing Significant Atrial Flutter
时间窗: Start (baseline) of first vernakalant infusion up to 24 hours after the last infusion
次要结局
- Number of Participants Who Are Converted to Sinus Rhythm for at Least One Minute(Up to 90 minutes after the start (baseline) of first infusion of vernakalant)