RecruitingNot ApplicableNCT05643235

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

Sponsor

Northwell Health

Enrollment

50 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia Atrial Fibrillation Supraventricular Arrhythmia Ventricular Arrhythmias and Cardiac Arrest Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is placing a small heart monitor (called an implanted loop recorder) in people about to start a cancer drug called a BTK inhibitor, to detect heart rhythm problems (arrhythmias) that these drugs are known to sometimes cause. This helps researchers understand the true rate and timing of these heart complications. **You may be eligible if...** - You are over 18 years old - You are about to start a BTK inhibitor drug (used for conditions like CLL or Waldenstrom's lymphoma) - You are willing to have a small heart monitor placed under your skin - You do not have a history of irregular heart rhythms in the past year **You may NOT be eligible if...** - You have had atrial fibrillation or a significant abnormal heart rhythm in the past 12 months - You have had a stroke or mini-stroke in the past year - You already have a pacemaker, defibrillator, or other cardiac device - You had heart surgery or a heart attack in the past 90 days - You are already taking a blood thinner or anti-arrhythmic medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMedtronic 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