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

Northwell Health

Status: Enrolling

Conditions: Atrial Fibrillation; Ventricular Arrhythmias and Cardiac Arrest; Supraventricular Arrhythmia; Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

Study type: Interventional

Funder types: Other

Identifiers

NCT05643235

ERP-2021-12882 (Other Grant/Funding Number)

IRB 22-0256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR

Other group

Description:

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.

Treatment:

Device: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)