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

January 3, 2024 updated by: Robert Copeland-Halperin, MD FACC, Northwell Health

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Robert S Copeland-Halperin, MD
  • Phone Number: 718-470-7330

Study Locations

  • United States
    • New York
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Northwell (Northshore University/Long Island Jewish Hospitals)
        • Contact:
        • Contact:
          • Robert S. Copeland-Halperin, MD
          • Phone Number: 718-470-7330
        • Sub-Investigator:
          • Michelle Jaeger, NP
        • Sub-Investigator:
          • Nandanee Karan
        • Sub-Investigator:
          • Joanna Rhodes, MD
        • Sub-Investigator:
          • Nicholas Beccarino, MD
        • Sub-Investigator:
          • Jason Ng, MD
        • Sub-Investigator:
          • Haisam Ismail, MD
        • Principal Investigator:
          • Robert Copeland-Halperin, MD
        • Principal Investigator:
          • Laurence Epstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR
Patients free of documented arrhythmia initiating treatment with a BTK inhibitor who consent to monitoring using the Medtronic LINQ-2 implanted cardiac monitoring device (ILR) prior to initiating BTK inhibitor therapy.
Device: Medtronic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 18 months after start of BTK inhibitor
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.
up to 60 months after device implantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 18 months after start of BTK inhibitor
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.
up to 60 months after device implantation
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
up to 60 months after device implantation
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.
up to 60 months after device implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Robert S Copeland-Halperin, MD, Northwell Health
  • Principal Investigator: Haisam Ismail, MD, Northwell Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

November 22, 2022

First Submitted That Met QC Criteria

December 1, 2022

First Posted (Actual)

December 8, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 22-0256
  • ERP-2021-12882 (Other Grant/Funding Number: Medtronic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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