Ibrutinib-Associated Atrial Fibrillation.
Sarju Ganatra, Ajay Sharma, Sachin Shah...
https://pubmed.ncbi.nlm.nih.gov/30573111Actively Recruiting
Led by Northwell Health · Updated on 2025-09-18
50
Participants Needed
1
Research Sites
208 weeks
Total Duration
Researchers are evaluating the use of Medtronic LINQ-2 insertable cardiac monitors (ILR) to detect new onset atrial fibrillation (AF) and other arrhythmias in patients starting treatment with Bruton Tyrosine Kinase (BTK) inhibitors. This study aims to understand how often arrhythmias develop during BTK inhibitor therapy and what actions are taken when arrhythmias are detected. The study is prospective and non-blinded and focuses on patients without prior documented arrhythmias. The study involves implanting the Medtronic LINQ-2 cardiac monitor in 50 patients who are beginning BTK inhibitor treatment for approved conditions such as chronic lymphocytic leukemia. The device is implanted by a certified electrophysiologist at least 24 hours before starting BTK therapy. Patients will be monitored continuously with the device for up to 60 months or until they withdraw consent or have the device removed. Participants will be remotely monitored for arrhythmias during the study period. Researchers will record incidence rates of atrial fibrillation and ventricular arrhythmias at 18 months and long-term up to 60 months. They will also track any changes to BTK inhibitor dosing, initiation of anticoagulation, and clinical actions resulting from device-detected arrhythmias. The study includes regular data collection from device monitoring and chart reviews to assess outcomes and safety.
CONDITIONS
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants have the Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) implanted by a certified electrophysiologist to enable continuous cardiac monitoring.
1 visit (in-person)
Duration - Up to 60 months or until device removal or withdrawal of consent
Participants are monitored continuously with the implanted cardiac monitor to detect arrhythmias while undergoing treatment with BTK inhibitors.
Remote monitoring with periodic follow-up visits as needed
Total: 1 location
1
Northwell (Northshore University/Long Island Jewish Hospitals)
New Hyde Park, New York, United States, 11040
Actively Recruiting
E
Efstathia Mihelis
R
Robert S Copeland-Halperin, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Sarju Ganatra, Ajay Sharma, Sachin Shah...
https://pubmed.ncbi.nlm.nih.gov/30573111Florian Baptiste, Jennifer Cautela, Yan Ancedy...
https://pubmed.ncbi.nlm.nih.gov/31168393Avirup Guha, Mohamed H Derbala, Qiuhong Zhao...
https://pubmed.ncbi.nlm.nih.gov/30072003Benjamin L Lampson, Lijian Yu, Robert J Glynn...
https://pubmed.ncbi.nlm.nih.gov/28223277John C Byrd, Peter Hillmen, Susan O'Brien...
https://pubmed.ncbi.nlm.nih.gov/30842083Constantine S Tam, Stephen Opat, Shirley D'Sa...
https://pubmed.ncbi.nlm.nih.gov/32731259Talha Munir, Jennifer R Brown, Susan O'Brien...
https://pubmed.ncbi.nlm.nih.gov/31512258John C Byrd, Peter Hillmen, Paolo Ghia...
https://pubmed.ncbi.nlm.nih.gov/34310172Rafi Sakhi, Dominic A M J Theuns, Tamas Szili-Torok...
https://pubmed.ncbi.nlm.nih.gov/30522350Rafi Sakhi, Roy Huurman, Dominic A M J Theuns...
https://pubmed.ncbi.nlm.nih.gov/33477163