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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Supraventricular Arrhythmia; Ventricular Arrhythmias and Cardiac Arrest; Chronic Lymphocytic Leukemia
• Interventions: Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

• Registration Number: NCT05643235
• Lead Sponsor: Northwell Health

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-08
• Study Start: 2023-01-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-05-01
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR	Medtronic LINQ-2 Insertable Cardiac Monitor (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.

Primary Outcome Measures

Name	Time	Method
Long term Incidence of device detected AF	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.
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.

Secondary Outcome Measures

Name	Time	Method
Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review	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
BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.	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.
Long term incidence of device detected ventricular arrhythmia (VA)	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.
Incidence of device detected ventricular arrhythmia (VA)	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.

Trial Locations

Locations (1)

Northwell (Northshore University/Long Island Jewish Hospitals); 🇺🇸 New Hyde Park, New York, United States