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

Part of paid clinical trials in New Hyde Park, New York.

Sponsor
Northwell Health
Study ID
NCT05643235
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) — DEVICE
    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

Study Details

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.

Key Dates

Start date
Jan 1, 2023
Status verified
Sep 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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.

Primary Outcome Measure

Incidence of device detected atrial fibrillation (AF) [ Time Frame: at 18 months after start of BTK inhibitor ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell (Northshore University/Long Island Jewish Hospitals)New Hyde ParkNew York11040
Efstathia A Mihelis
[email protected]
212-434-6614
Robert S. Copeland-Halperin, MD
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)

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Northwell (Northshore University/Long Island Jewish Hospitals)· New Hyde Park, NY

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