Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \>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
Locations
United States
New York
Northwell (Northshore University/Long Island Jewish Hospitals)
RECRUITING
New Hyde Park
Contact Information
Primary
Efstathia Mihelis
emihelis@northwell.edu
212-434-6614
Backup
Robert S Copeland-Halperin, MD
718-470-7330
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health