Chronic Lymphocytic Leukemia Clinical Trial

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

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.

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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.

View Eligibility Criteria

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. leukemia-cll/" >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 is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

50

Study ID:

NCT05643235

Recruitment Status:

Recruiting

Sponsor:

Northwell Health

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There is 1 Location for this study

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Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park New York, 11040, United States More Info
Efstathia A Mihelis
Contact
212-434-6614
[email protected]
Robert S. Copeland-Halperin, MD
Contact
718-470-7330
Michelle Jaeger, NP
Sub-Investigator
Nandanee Karan
Sub-Investigator
Joanna Rhodes, MD
Sub-Investigator
Nicholas Beccarino, MD
Sub-Investigator
Jason Ng, MD
Sub-Investigator
Haisam Ismail, MD
Sub-Investigator
Robert Copeland-Halperin, MD
Principal Investigator
Laurence Epstein, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Chronic Lymphocytic Leukemia

Estimated Enrollment:

50

Study ID:

NCT05643235

Recruitment Status:

Recruiting

Sponsor:


Northwell Health

How clear is this clinincal trial information?

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