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Device

Implanted Loop Recorder for Arrhythmia Detection

N/A
Recruiting
Led By Robert S Copeland-Halperin, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>18 years old
Initiating BTK inhibitor for approved condition (i.e. CLL, Waldenstrom's, etc)
Must not have
Patient is taking an anti-arrhythmic or anticoagulant
Heart surgery within past 90 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 18 months after start of btk inhibitor
Awards & highlights

Summary

This trial uses BTK inhibitors and a small heart monitor device to track new heart rhythm issues in patients starting these medications who have no prior history of such problems. The drugs help stop cancer cell growth, while the monitor continuously records heart activity. Ibrutinib and other novel BTK inhibitors have been developed and tested for the treatment of B-cell malignancies and autoimmune disorders.

Who is the study for?
Adults over 18 starting Bruton Tyrosine Kinase inhibitors for conditions like CLL, who agree to heart monitoring and haven't had arrhythmias or strokes in the past year. Excludes those with recent heart surgery, myocardial infarction, other implants, or on anti-arrhythmic/anticoagulant drugs.
What is being tested?
The trial is testing if a Medtronic LINQ-2 Insertable Cardiac Monitor can detect new atrial fibrillation or other arrhythmias in patients beginning BTK inhibitor treatment without prior documented arrhythmia.
What are the potential side effects?
Potential side effects may include discomfort at the implant site, infection risk from the procedure, and possible allergic reactions to device materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am starting a BTK inhibitor treatment for my condition.
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I agree to have a heart monitor inserted before starting BTK inhibitor treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking medication for irregular heartbeat or blood thinning.
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I have not had heart surgery in the last 90 days.
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I have not had a stroke or mini-stroke in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 18 months after start of btk inhibitor
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 months after start of btk inhibitor for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of device detected atrial fibrillation (AF)
Long term Incidence of device detected AF
Secondary study objectives
BTK dose reduction or discontinuation due to device detected arrhythmia, assessed by chart review.
Incidence of device detected ventricular arrhythmia (VA)
Initiation of anticoagulation for AF detected by device monitoring, assessed by chart review
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILRExperimental Treatment1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Bruton Tyrosine Kinase (BTK) inhibitors, such as ibrutinib, acalabrutinib, and zanubrutinib, are common treatments for Chronic Lymphocytic Leukemia (CLL). These drugs work by inhibiting the BTK enzyme, which is essential for B-cell receptor signaling. By disrupting this pathway, BTK inhibitors prevent the survival and proliferation of malignant B-cells, which are characteristic of CLL. This targeted approach is significant for CLL patients as it offers a more precise treatment option, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
473 Previous Clinical Trials
472,146 Total Patients Enrolled
Robert S Copeland-Halperin, MDPrincipal InvestigatorNorthwell Health
Haisam Ismail, MDPrincipal InvestigatorNorthwell Health

Media Library

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05643235 — N/A
Chronic Lymphocytic Leukemia Research Study Groups: Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR
Chronic Lymphocytic Leukemia Clinical Trial 2023: Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) Highlights & Side Effects. Trial Name: NCT05643235 — N/A
Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643235 — N/A
~11 spots leftby May 2025