About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
>18yo
Willing to sign and date consent form,
Willing to be remotely monitored
Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
DevicePatients initiating BTK inhibitors will be offered the option of monitoring using the Medtronic Insertable Cardiac Monitor (ILR). The device will be implanted by a certified and credentialed electrophysiologist to enable monitoring to begin at least 24 hours prior to the first administration of the BTK inhibitor. Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months
Treatment groups
Trial outcomes
Primary outcomes
Incidence of device detected atrial fibrillation (AF)
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.
Long term Incidence of device detected AF
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.
Secondary outcomes
Incidence of device detected ventricular arrhythmia (VA)
Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate \> 100 beats per minute at 18 months after start of BTK inhibitor therapy.
BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.
Clinical actions including BTK dose reduction, interruption, discontinuation, or change in oncologic treatment by treating oncologist because of device detected arrhythmia.
Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review
Prescription of an approved anticoagulant drug (apixaban, dabigatran, rivaroxaban, edoxaban, warfarin, aspirin) for prevention of stroke/systemic embolism based on AF detected by ILR
Long term incidence of device detected ventricular arrhythmia (VA)
Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate \> 100 beats per minute up to 60 months after device implant.
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