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

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT05643235

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Supraventricular Arrhythmia Ventricular Arrhythmias and Cardiac Arrest Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma	Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single arm, prospective study of implanted loop recorders (ILR) for the detection of arrhythmia in patients initiating treatment with BTK inhibitors.Single arm, prospective study of implanted loop recorders (ILR) for the detection of arrhythmia in patients initiating treatment with BTK inhibitors.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Nov 1, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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