Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05643235

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

Led by Northwell Health · Updated on 2025-09-18

50

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Willing to sign and date the consent form
  • Willing to be remotely monitored
  • Starting BTK inhibitor treatment for an approved condition like chronic lymphocytic leukemia or Waldenstrom's
  • Agree to have the Medtronic cardiac monitor inserted for at least 24 hours of continuous monitoring before starting BTK therapy
Not Eligible

You will not qualify if you...

  • Documented atrial fibrillation or ventricular arrhythmia in the past 12 months
  • Stroke or transient ischemic attack in the past year
  • Current implanted pacemaker, defibrillator, pulse generator, or resynchronization device
  • Heart surgery within the past 90 days
  • Myocardial infarction within the past 90 days
  • Taking anti-arrhythmic or anticoagulant medications
  • Any condition that makes participation unsafe, such as substance abuse
  • Enrolled in another study that could affect results of this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

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)

Monitoring

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

Trial Site Locations

Total: 1 location

1

Northwell (Northshore University/Long Island Jewish Hospitals)

New Hyde Park, New York, United States, 11040

Actively Recruiting

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Research Team

E

Efstathia Mihelis

R

Robert S Copeland-Halperin, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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Published Research Related To This Trial

A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenström macroglobulinemia: the ASPEN study.

Constantine S Tam, Stephen Opat, Shirley D'Sa...

https://pubmed.ncbi.nlm.nih.gov/32731259

Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Talha Munir, Jennifer R Brown, Susan O'Brien...

https://pubmed.ncbi.nlm.nih.gov/31512258

Acalabrutinib Versus Ibrutinib in Previously Treated Chronic Lymphocytic Leukemia: Results of the First Randomized Phase III Trial.

John C Byrd, Peter Hillmen, Paolo Ghia...

https://pubmed.ncbi.nlm.nih.gov/34310172

Incremental Value of an Insertable Cardiac Monitor in Patients with Hypertrophic Cardiomyopathy with Low or Intermediate Risk for Sudden Cardiac Death.

Rafi Sakhi, Roy Huurman, Dominic A M J Theuns...

https://pubmed.ncbi.nlm.nih.gov/33477163