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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
Patients 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
Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park, New York, United States
RECRUITINGIncidence 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.
Time frame: at 18 months after start of BTK inhibitor
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.
Time frame: up to 60 months after device implantation
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.
Time frame: at 18 months after start of BTK inhibitor
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.
Time frame: up to 60 months after device implantation
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
Time frame: up to 60 months after device implantation
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.
Time frame: up to 60 months after device implantation
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