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Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors

RecruitingNAAges 18 Years - anyAllNorthwell Health
NCT05643235 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
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Where

1 site
Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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