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

RECRUITINGN/ASponsored by Northwell Health
Actively Recruiting
PhaseN/A
SponsorNorthwell Health
Started2023-01-01
Est. completion2026-12-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions7

Atrial FibrillationCancerChronic Lymphocytic LeukemiaChronic Lymphocytic Leukemia/Small Lymphocytic LymphomaHeart DiseaseSupraventricular ArrhythmiaVentricular Arrhythmias and Cardiac Arrest

Locations1 site

Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park, New York, 11040
Efstathia A Mihelis212-434-6614emihelis@northwell.edu

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