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Monitoring Heart Rhythms with an Implanted Device for Patients Starting BTK Inhibitors

This study is for people starting Bruton Tyrosine Kinase (BTK) inhibitors (like ibrutinib, acalabrutinib, zanubrutinib, or pirtobrutinib) for conditions like chronic lymphocytic leukemia (CLL), who haven't had heart rhythm problems recently. You would have a small device called a Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) placed under your skin. This device helps doctors detect new cases of atrial fibrillation (AF) and other irregular heartbeats. The study aims to see how often these heart rhythm issues occur after starting BTK inhibitors, with monitoring for up to 60 months. The goal is to understand how these medications might affect your heart rhythm and how doctors respond to any detected issues. About 50 people will participate.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It will involve 50 participants.
What's involved
You would have a Medtronic cardiac monitor inserted at least 24 hours before starting your BTK inhibitor. You would also need to be willing to be remotely monitored.
Compensation
Not stated in the trial record.
Follow-up
Your heart rhythm will be monitored for up to 60 months after the device is implanted, and the incidence of AF will be measured at 18 months and up to 60 months after starting the BTK inhibitor.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05643235

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

Recruiting
NAAges 18+Interventional
Northwell Health
~50 participants
Updated 2025-09-18 on ClinicalTrials.gov
What's tested:Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of device detected atrial fibrillation (AF)
Measured over at 18 months after start of BTK inhibitor
+1 more outcome measured

Conditions

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

Explore related trials

Chronic Lymphocytic LeukemiaMantle Cell LymphomaWaldenstrom Macroglobulinemia

NCT05643235

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwell (Northshore University/Long Island Jewish Hospitals)

    New Hyde Park, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Robert S Copeland-Halperin, MD · PRINCIPAL_INVESTIGATOR · Northwell Health
  • Haisam Ismail, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

Efstathia Mihelis
[email protected]
212-434-6614
Email the study team

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Eligibility criteria

Inclusion

\>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

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

What this trial measures

  • Incidence of device detected atrial fibrillation (AF)at 18 months after start of BTK inhibitor

    Incidence of AF lasting 6 or more minutes at 18 months: each arrhythmic episode detected by the patient's device will be reviewed to determine if it is 1) an actual AF episode, and 2) is at least 6 minutes in duration.

  • Long term Incidence of device detected AFup to 60 months after device implantation

    Incidence of AF lasting 6 or more minutes up to 60 months: each arrhythmic episode detected by the patient's device will be reviewed to determine if it is 1) an actual AF episode, and 2) is at least 6 minutes in duration.