Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Long term Incidence of device detected AF
研究概览
简要总结
This study will enroll patients initiating Bruton Tyrosine Kinase (BTK) inhibitors without history of documented arrhythmia while on therapy using the Medtronic LINQ-2 insertable cardiac monitor (ILR). The incidence of new onset atrial fibrillation (AF) and other arrhythmia will be determined. Actions taken in response to device detected arrhythmia will be recorded.
详细描述
This single arm, prospective non-blinded study will enroll 50 patients initiating treatment with BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib or pirtobrutinib) without documented arrhythmia prior to starting BTK inhibitor therapy, without contraindications to an implanted loop recorder (ILR). They will be offered the option of monitoring arrhythmias using the Medtronic LINQ-2 insertable cardiac monitor (ILR). Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months. Investigators hope to obtain information on arrhythmia incidence including AF, ventricular arrhythmia (VA), and actions taken in response to awareness of such episodes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Willing to sign and date consent form,
- •Willing to be remotely monitored
- •Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)
- •Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor
排除标准
- •Documented AF/VA in past 12 months
- •Cerebral Vascular Accident (CVA) or Transient Ischemic Attack (TIA) in past year
- •Has current implanted pulse generator, defibrillator, pacemaker, or resynchronization device
- •heart surgery within past 90 days
- •Myocardial Infarction within past 90 days
- •Patient is taking an anti-arrhythmic or anticoagulant
- •has concomitant condition that precludes safe participation in study (substance abuse, etc)
- •Enrollment in separate study that could confound results of this study
结局指标
主要结局
Long term Incidence of device detected AF
时间窗: up to 60 months after device implantation
Incidence of AF lasting 6 or more minutes up to 60 months: each arrhythmic episode detected by the patient's device will be reviewed to determine if it is 1) an actual AF episode, and 2) is at least 6 minutes in duration.
Incidence of device detected atrial fibrillation (AF)
时间窗: at 18 months after start of BTK inhibitor
Incidence of AF lasting 6 or more minutes at 18 months: each arrhythmic episode detected by the patient's device will be reviewed to determine if it is 1) an actual AF episode, and 2) is at least 6 minutes in duration.
次要结局
- Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review(up to 60 months after device implantation)
- BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.(up to 60 months after device implantation)
- Long term incidence of device detected ventricular arrhythmia (VA)(up to 60 months after device implantation)
- Incidence of device detected ventricular arrhythmia (VA)(at 18 months after start of BTK inhibitor)
研究者
Robert Copeland-Halperin, MD FACC
Assistant Professor of Cardiology
Northwell Health