ClinicalTrials.gov record NCT05643235
Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors
Implanted Loop Recorders (ILR) for the Detection and Management of Arrhythmia in Patients Treated With Bruton Tyrosine Kinase (BTK) Inhibitors
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This single-group study offers implantation of a Medtronic LINQ-2 insertable cardiac monitor (ILR) to people starting Bruton tyrosine kinase (BTK) inhibitor treatment without prior documented arrhythmia. Up to 50 participants will begin monitoring at least 24 hours before their first BTK dose and will be followed by device data until device removal, withdrawal, or for up to 60 months. The study will record how often atrial fibrillation and other arrhythmias are detected and what clinical actions follow.
What it is studying. The study is testing continuous implanted cardiac monitoring to measure how often new atrial fibrillation (AF) and other arrhythmias occur in people starting BTK inhibitors, and to document clinical responses to device-detected events (for example, changes in BTK dosing or start of anticoagulation). It includes primary measures of AF episodes lasting six or more minutes at 18 months and up to 60 months, and measures of ventricular arrhythmia and related clinical actions.
What the researchers hope to learn. Collect data on the incidence of device-detected atrial fibrillation (episodes ≥6 minutes) at 18 months and up to 60 months; measure incidence of device-detected ventricular arrhythmia (≥3 sequential wide complex ventricular beats >100 bpm) at 18 months and up to 60 months; and record clinical actions after device-detected arrhythmias, including BTK dose changes or discontinuation and initiation of anticoagulation.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you join, a small implantable heart monitor (Medtronic LINQ-2) will be inserted by a certified electrophysiologist so monitoring can begin at least 24 hours before your first BTK dose. The device will continuously record heart rhythm and send data remotely; monitoring will continue until you withdraw consent, the device is removed, or for up to 60 months. Study staff will review device-detected arrhythmias and your medical records to document arrhythmia episodes and any clinical actions taken (for example, BTK dose changes or initiation of anticoagulation). You will be asked to provide informed consent and to accept remote monitoring.
How the study is structured. This is a single-group, prospective, non-blinded interventional study in which participants receive the Medtronic LINQ-2 insertable cardiac monitor (ILR). The ILR is implanted by a qualified electrophysiologist so monitoring begins at least 24 hours before the first BTK inhibitor dose. Device data are collected prospectively until the participant withdraws consent, the device is removed, or for up to 60 months. The study plans to enroll about 50 participants.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Jan 1, 2023
- Primary completion
- Dec 1, 2026 (estimated)
- Study completion
- Dec 1, 2030 (estimated)
- Target enrollment
- 50 participants (estimated)
- Last updated on registry
- Sep 18, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Northwell Health
- Principal investigator
- Robert Copeland-Halperin, MD FACC, Assistant Professor of Cardiology
Northwell Health
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Efstathia Mihelis 📞 212-434-6614 ✉ emihelis@northwell.edu
- Robert S Copeland-Halperin, MD 📞 718-470-7330
Participating sites (1)
- Northwell (Northshore University/Long Island Jewish Hospitals)Recruiting
New Hyde Park, New York, 11040 · United States
- Efstathia A Mihelis · 212-434-6614 · emihelis@northwell.edu
- Robert S. Copeland-Halperin, MD · 718-470-7330
- Michelle Jaeger, NP
- Nandanee Karan
- Joanna Rhodes, MD
- Nicholas Beccarino, MD
- Jason Ng, MD
- Haisam Ismail, MD
- Robert Copeland-Halperin, MD
- Laurence Epstein, MD
Terms used on this page · explanations by MedicalUpdates.ai
- Enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- single arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- blinded
- Who does not know which intervention a participant is receiving. It can apply to participants, the people giving the treatment, those assessing results, or those analysing the data.
- contraindications
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials