NCT04118530已完成不适用
Long Term Arrhythmia Risk and Cardiovascular Events in Hematopoietic Stem Cell Transplant Survivors: Reveal Linq Cancer Registry Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Recurrent AF/AFL episodes
研究概览
简要总结
The purpose of this study is to better understand the following aims:
- Aim 1: To evaluate the rate of recurrent Atrial Fibrillation (AF)/Atrial Flutter (AFL) in hematopoietic stem call transplant (HCST) patients with incident AF/AFL identified during the initial 30 days of the transplant
- Aim 2: To evaluate incident episodes of 1) stroke/TIA; 2) other thromboembolic events (not stroke/TIA); 3) Heart failure events; 4) Ischemic heart events
- Aim 3: To evaluate overall implantation safety in this population
详细描述
We propose a registry study in hematopoietic stem cell transplant (HSCT) patients with incident atrial fibrillation/atrial flutter (AF/AFL) during the initial 30 days of transplant who will be implanted with the Medtronic Reveal Linq Implantable Cardiac Monitor (ICM) within 90 days of HSCT. We will evaluate the rate of recurrent AF/AFL as well as incident episodes of major cardiovascular events and the safety of ICM implantation in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHADS-VASc ≥ 2
- •Recovery of platelets to >50,000 within 90 days of incident atrial fibrillation (AF) diagnosis
- •Discharge from the incident stem cell transplant (SCT) hospitalization
- •Normal sinus rhythm at the time of consent
排除标准
- •Prior history of atrial fibrillation (AF) or atrial flutter
- •CHADS-VASc <2
- •Platelets <50,000 after 90 days post transplantation
- •Continued SCT hospitalization at 90 days
- •Inability to receive anticoagulation
- •AF or other arrhythmia at the time of consent
- •Current use of a class IC or III antiarrhythmic medication
- •Inability to provide informed consent/significant cognitive impairment
- •Expected survival less than one year.
结局指标
主要结局
Recurrent AF/AFL episodes
时间窗: 1 year
Any recurrent episodes of AF/AFL lasting ≥2 minutes identified in ICM monitoring
次要结局
- Incident Episodes of Interest(1 year)
研究者
研究点 (1)
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