Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
Northwell Health
50 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- \>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)
- Willing to have Medtronic cardiac monitor inserted to allow at minimum 24 hours continuous monitoring prior to initiating BTK inhibitor
Exclusion Criteria8
- 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
Interventions
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
Locations(1)
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NCT05643235