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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 months after start of btk inhibitor

Awards & highlights

Study Summary

This trial will track patients starting a new drug to see if it causes heart rhythm problems. Action taken if problems occur will be noted.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 months after start of btk inhibitor

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of device detected atrial fibrillation (AF)

Long term Incidence of device detected AF

Secondary outcome measures

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,993 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this clinical investigation?

"Indeed, clinicaltrials.gov attests that this research project is currently recruiting for participants. The original post was dated November 1st 2022 with the most recent changes taking effect on December 1st 2022. 50 people need to be recruited from one medical facility."

Answered by AI

What key objectives are being pursued through this research project?

"The primary objectives of this 18-month clinical trial is to determine the long-term incidence of device detected atrial fibrillation (AF). Secondary targets include BTK dose reduction or discontinuation due to arrhythmia, initiation of anticoagulation for AF detection by ILR monitoring, and long-term occurrence of ventricular arrhythmias."

Answered by AI

How many participants is this study currently accommodating?

"Affirmative, information on clinicaltrials.gov suggests that this research experiment is still recruiting participants. It was initially posted in November 1st 2022 and last modified December 1st 2022. The trial will involve 50 individuals at a single location."

Answered by AI

Recent research and studies

JAMA CardiologyJournal

Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-risk Population

Reiffel, James A., Atul Verma, Peter R. Kowey, Jonathan L. Halperin, Bernard J. Gersh, Rolf Wachter, Erika Pouliot, Paul D. Ziegler, and for the REVEAL AF Investigators. 2017. “Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-risk Population”. JAMA Cardiology. American Medical Association (AMA). doi:10.1001/jamacardio.2017.3180.

clinicaltrials.govStudy

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

Robert Copeland-Halperin, MD FACC 2023. "Implanted Loop Recorders for Detection and Management of Arrhythmia With Bruton Tyrosine Kinase Inhibitors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05643235.

All > Afib > Atrial Fibrillation