Chronic Lymphocytic Leukemia Clinical Trial
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
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.
Willing to sign and date consent form,
Willing to be remotely monitored
Initiating BTK inhibitor for approved condition (i.e. leukemia-cll/" >CLL, Waldenstrom's, etc)
Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor
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
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There is 1 Location for this study
New Hyde Park New York, 11040, United States More Info
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