RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - \>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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * \>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 Criteria: * 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

Treatments Being Tested

DEVICE

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

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)

Northwell (Northshore University/Long Island Jewish Hospitals)

New Hyde Park, New York, United States