Atrial Fibrillation, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Supraventricular Arrhythmia, Ventricular Arrhythmias and Cardiac Arrest
Conditions
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)
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.
Interventions
DEVICEMedtronic 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
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single arm, prospective study of implanted loop recorders (ILR) for the detection of arrhythmia in patients initiating treatment with BTK inhibitors.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactEfstathia Mihelis
Backup ContactRobert S Copeland-Halperin, MD
Outcome results
None listed