Clinical trial NCT05643235: Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
Official title: Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Supraventricular Arrhythmia
Ventricular Arrhythmias and Cardiac Arrest
Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Keywords: Bruton tyrosine kinase (BTK)
Chronic Lymphocytic Leukemia (CLL)
Mantle Cell Lymphoma
Waldenstrom's macroglobulinemia
atrial fibrillation (AF)
ventricular arrhythmia (VA)
sudden cardiac death
ibrutinib
acalabrutinib
zanubrutinib
pirtobrutinib
Implanted Loop Recorder/Implanted Cardiac Monitor (ILR)
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, prospective study of implanted loop recorders (ILR) for the detection of arrhythmia in patients initiating treatment with BTK inhibitors.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of device detected atrial fibrillation (AF)
timeFrame: at 18 months after start of BTK inhibitor
measure: Long term Incidence of device detected AF
timeFrame: up to 60 months after device implantation
Secondary outcomes:
measure: Incidence of device detected ventricular arrhythmia (VA)
timeFrame: at 18 months after start of BTK inhibitor
measure: BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.
timeFrame: up to 60 months after device implantation
measure: Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review
timeFrame: up to 60 months after device implantation
measure: Long term incidence of device detected ventricular arrhythmia (VA)
timeFrame: up to 60 months after device implantation
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Northwell (Northshore University/Long Island Jewish Hospitals)
state: New York
Study officials:
affiliation: Northwell Health
name: Robert S Copeland-Halperin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: Haisam Ismail, MD
role: PRINCIPAL_INVESTIGATOR
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