Ventricular arrhythmias and sudden death in patients taking ibrutinib.
Benjamin L Lampson, Lijian Yu, Robert J Glynn...
https://pubmed.ncbi.nlm.nih.gov/28223277/Actively Recruiting
Led by Northwell Health · Updated on 2025-09-18
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
Researchers are evaluating the use of Medtronic LINQ-2 insertable cardiac monitors ILR to detect new onset atrial fibrillation AF and other arrhythmias in patients starting treatment with Bruton Tyrosine Kinase BTK inhibitors. This study aims to understand how often arrhythmias develop during BTK inhibitor therapy and what actions are taken when arrhythmias are detected. The study is prospective and non-blinded and focuses on patients without prior documented arrhythmias. The study involves implanting the Medtronic LINQ-2 cardiac monitor in 50 patients who are beginning BTK inhibitor treatment for approved conditions such as chronic lymphocytic leukemia. The device is implanted by a certified electrophysiologist at least 24 hours before starting BTK therapy. Patients will be monitored continuously with the device for up to 60 months or until they withdraw consent or have the device removed. Participants will be remotely monitored for arrhythmias during the study period. Researchers will record incidence rates of atrial fibrillation and ventricular arrhythmias at 18 months and long-term up to 60 months. They will also track any changes to BTK inhibitor dosing, initiation of anticoagulation, and clinical actions resulting from device-detected arrhythmias. The study includes regular data collection from device monitoring and chart reviews to assess outcomes and safety.
CONDITIONS
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
E
Efstathia Mihelis
R
Robert S Copeland-Halperin, MD
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Northwell Health
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Medtronic Insertable Cardiac Monitor With BTK Inhibitor | Usual Cardiac Surveillance (ECG, Event Monitoring Only if Symptoms) |
|---|---|---|
| What it is | Continuous arrhythmia monitoring with an implantable loop recorder (Medtronic LINQ-2) implanted before starting BTK inhibitor therapy, specifically to detect atrial and ventricular arrhythmias in high-risk hematology patients. | Routine cardiac monitoring involving clinical evaluation, resting ECG at baseline and follow-up, and event monitoring only if symptoms arise. Insertable cardiac monitors are not routinely used in this setting and are reserved for highly selected cases. |
| Role in trial | Defines the only active study group: high-risk CLL/lymphoma patients starting BTK inhibitors are monitored intensively for arrhythmias with the Medtronic ILR for up to 5 years. | Provides the current monitoring practice used for similar patients outside the trial. Relies on clinical evaluation and ECG monitoring only, unless specific indications arise for extended arrhythmia surveillance. |
| Primary use | To detect episodes of atrial fibrillation or ventricular arrhythmias during and after BTK inhibitor therapy, including events that may not cause symptoms. | To identify significant arrhythmic events if symptoms (such as palpitations, syncope, or chest discomfort) prompt investigation, or if an event is noted on routine follow-up ECG. |
| How it is given or performed | Device is implanted by an electrophysiologist at least 24 hours before BTK inhibitor initiation. Monitoring data is collected continuously and remotely for up to 60 months or until device removal or withdrawal. | Patients receive clinical evaluation with ECG before and during treatment. Event monitors or Holter monitors may be used if cardiac symptoms occur, but continuous monitoring devices are not part of routine care for BTK inhibitor initiation. |
| Published evidence status | The trial is ongoing; results regarding the detection rate of arrhythmias using ILR in this high-risk BTKi-treated population are not yet established. | Published evidence shows arrhythmia detection in BTK inhibitor–treated patients is mainly symptom-triggered and may under-recognize asymptomatic events. Intensive monitoring with ILRs detects more asymptomatic cases in other risk groups, but this approach is not standard for BTK inhibitor monitoring. |
| Important limitations | Requires device implantation, specialist procedure, and long-term device management. Generalizability is limited to closely monitored research patients, and the contribution of device-detected arrhythmias to clinical outcomes remains investigational. | Routine practice may miss asymptomatic arrhythmias and does not provide continuous data. Event monitoring typically requires patient-initiated reporting or investigation of symptoms, which can delay diagnosis of silent events. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have the Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) implanted by a certified electrophysiologist to enable continuous cardiac monitoring.
1 visit (in-person)
Duration - Up to 60 months or until device removal or withdrawal of consent
Participants are monitored continuously with the implanted cardiac monitor to detect arrhythmias while undergoing treatment with BTK inhibitors.
Remote monitoring with periodic follow-up visits as needed
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/33477163/Northwell Health
Lead Sponsor