Recruiting

BTK Inhibitors

Sponsor:

Northwell Health

Code:

NCT05643235

Conditions

Atrial Fibrillation

Supraventricular Arrhythmia

Ventricular Arrhythmias and Cardiac Arrest

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

Study Details

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.

Conditions

Atrial Fibrillation

Supraventricular Arrhythmia

Ventricular Arrhythmias and Cardiac Arrest

Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Study ID

NCT05643235

Start date

Jan 1, 2023

Status verified date

Sep, 2025

Completion date

Dec 1, 2030

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Incidence of device detected atrial fibrillation (AF) [ Time Frame: at 18 months after start of BTK inhibitor ]
  • Long term Incidence of device detected AF [ Time Frame: up to 60 months after device implantation ]

Central Contacts and Locations

Central contacts

Efstathia Mihelis

212-434-6614emihelis@northwell.edu

Robert S Copeland-Halperin, MD

718-470-7330

Locations

Northwell (Northshore University/Long Island Jewish Hospitals)

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Efstathia A Mihelis

212-434-6614emihelis@northwell.edu

Robert S. Copeland-Halperin, MD

718-470-7330

Principal Investigator:

Robert Copeland-Halperin, MD

More Information

Sponsor

Northwell Health

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-09-18.