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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILROther 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of device detected atrial fibrillation (AF)

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.

Time frame
at 18 months after start of BTK inhibitor
2

Long term Incidence of device detected AF

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.

Time frame
up to 60 months after device implantation

Secondary outcomes

1

Incidence of device detected ventricular arrhythmia (VA)

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.

Time frame
at 18 months after start of BTK inhibitor
2

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

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

Time frame
up to 60 months after device implantation
3

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

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

Time frame
up to 60 months after device implantation
4

Long term incidence of device detected ventricular arrhythmia (VA)

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.

Time frame
up to 60 months after device implantation

Other outcomes

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