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NCT Number: NCT05643235

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

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Death Death, Sudden Death, Sudden, Cardiac Disease Attributes Heart Arrest Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Supraventricular Arrhythmia Vascular Diseases Ventricular Arrhythmias and Cardiac Arrest Waldenstrom Macroglobulinemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell (Northshore University/Long Island Jewish Hospitals)

New Hyde Park, New York, 11040, United States

Location status: Recruiting

Location contact

Efstathia A Mihelis

CONTACT

[email protected]

212-434-6614

Haisam Ismail, MD

SUB_INVESTIGATOR

Jason Ng, MD

SUB_INVESTIGATOR

Joanna Rhodes, MD

SUB_INVESTIGATOR

Laurence Epstein, MD

PRINCIPAL_INVESTIGATOR

Michelle Jaeger, NP

SUB_INVESTIGATOR

Nandanee Karan

SUB_INVESTIGATOR

Nicholas Beccarino, MD

SUB_INVESTIGATOR

Robert Copeland-Halperin, MD

PRINCIPAL_INVESTIGATOR

Robert S. Copeland-Halperin, MD

CONTACT

718-470-7330

About this study

This single arm, prospective non-blinded study will enroll 50 patients initiating treatment with BTK inhibitors (ibrutinib, acalabrutinib, zanubrutinib or pirtobrutinib) without documented arrhythmia prior to starting BTK inhibitor therapy, without contraindications to an implanted loop recorder (ILR). They will be offered the option of monitoring arrhythmias using the Medtronic LINQ-2 insertable cardiac monitor (ILR). Monitoring data will be collected prospectively until the patient withdraws consent, the device is removed, or up to 60 months. Investigators hope to obtain information on arrhythmia incidence including AF, ventricular arrhythmia (VA), and actions taken in response to awareness of such episodes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

Device

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

Primary outcomes

  1. Incidence of device detected atrial fibrillation (AF)

    Time frame: 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.

  2. Long term Incidence of device detected AF

    Time frame: up 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.

Secondary outcomes

  1. Incidence of device detected ventricular arrhythmia (VA)

    Time frame: at 18 months after start of BTK inhibitor

    Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate > 100 beats per minute at 18 months after start of BTK inhibitor therapy.

  2. BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.

    Time frame: up to 60 months after device implantation

    Clinical actions including BTK dose reduction, interruption, discontinuation, or change in oncologic treatment by treating oncologist because of device detected arrhythmia.

  3. Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review

    Time frame: up to 60 months after device implantation

    Prescription of an approved anticoagulant drug (apixaban, dabigatran, rivaroxaban, edoxaban, warfarin, aspirin) for prevention of stroke/systemic embolism based on AF detected by ILR

  4. Long term incidence of device detected ventricular arrhythmia (VA)

    Time frame: up to 60 months after device implantation

    Incidence of VA is defined as follows: greater than or equal to 3 sequential wide complex beats arising from the ventricles, rate > 100 beats per minute up to 60 months after device implant.

Study contacts

Contact information is provided by the study sponsor or research team.

Efstathia Mihelis

CONTACT

[email protected]

212-434-6614

Robert S Copeland-Halperin, MD

CONTACT

718-470-7330

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors

Important dates

Study start
2023
Primary completion
2026
Study completion
2030
First posted
Dec 8, 2022
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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