Implanted Loop Recorder for Arrhythmia Detection

Overseen By Efstathia Mihelis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwell Health

Must be taking: BTK inhibitors

Must not be taking: Anti-arrhythmics, Anticoagulants

Disqualifiers: Arrhythmia, CVA, TIA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a small heart monitor, the Medtronic LINQ-2 Insertable Cardiac Monitor (ILR), can detect irregular heart rhythms, such as atrial fibrillation, in individuals starting a specific cancer treatment called Bruton Tyrosine Kinase inhibitors. The trial tracks the frequency of these heart issues and the actions taken in response. Candidates may qualify if they are beginning this cancer treatment, have no history of certain heart problems, and are open to using a device for heart monitoring. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance heart monitoring for cancer patients.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking any anti-arrhythmic or anticoagulant medications. If you are on these medications, you would need to stop them to participate.

What prior data suggests that the Medtronic LINQ-2 insertable cardiac monitor is safe for arrhythmia detection?

Research has shown that the Medtronic LINQ-2 insertable cardiac monitor (ICM) is generally well-tolerated. This small device is placed under the skin to monitor heart rhythms over an extended period. Studies have found it can track heart activity for up to three years without issues.

Most people do not experience serious side effects from the device implantation. Some common, mild side effects may include minor skin reactions or discomfort at the insertion site, but these usually resolve on their own.

The LINQ-2 is already approved and used in hospitals for heart monitoring, indicating it is considered safe. Overall, the LINQ-2 ICM is a reliable tool for tracking heart rhythms, with minimal risk of serious complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

While most arrhythmia detection methods rely on external devices or short-term monitoring, the Medtronic LINQ-2 Insertable Cardiac Monitor offers a unique approach by being implanted under the skin for continuous, long-term monitoring. This allows for more accurate and comprehensive detection of irregular heart rhythms over extended periods. Researchers are excited about this device because it provides real-time data without interrupting daily activities, potentially leading to earlier and more precise diagnosis of arrhythmias. Unlike traditional methods that may miss sporadic episodes, the LINQ-2's continuous monitoring could significantly improve patient outcomes.

What evidence suggests that the Medtronic LINQ-2 insertable cardiac monitor is effective for arrhythmia detection?

Research has shown that the Medtronic LINQ-2 Insertable Cardiac Monitor (ICM) effectively monitors the heart over the long term. It detects irregular heartbeats, such as atrial fibrillation, by tracking heart rhythms over time. Studies have found that these monitors are cost-effective and improve diagnosis in patients with unexplained symptoms. In this trial, patients who begin treatment with Bruton tyrosine kinase inhibitors will consent to the installation of the LINQ-2 device for monitoring. The LINQ-2 uses advanced AI technology to collect accurate information about heart activity. This data helps doctors better understand heart conditions and make informed treatment decisions. ^{1 3 6 7 8}

Who Is on the Research Team?

Robert S Copeland-Halperin, MD

Principal Investigator

Northwell Health

Haisam Ismail, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing to be remotely monitored

I am older than 18 years.

I am starting a BTK inhibitor treatment for my condition.

Exclusion Criteria

Has concomitant condition that precludes safe participation in study (substance abuse, etc)

I have not had heart surgery in the last 90 days.

I am currently taking medication for irregular heartbeat or blood thinning.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Initiation

Patients initiate treatment with Bruton Tyrosine Kinase inhibitors and consent to the installation of the Medtronic LINQ-2 insertable cardiac monitor (ILR)

1-2 weeks

1 visit (in-person) for device implantation

Monitoring

Continuous monitoring of arrhythmias using the ILR device, with data collection on arrhythmia incidence and clinical actions taken in response

60 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients initiated on Bruton tyrosine kinase inhibitors, consenting to installment of ILR Experimental Treatment 1 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.

Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medtronic LINQ-2 ILR for:

• Detection and management of arrhythmia
• Monitoring for atrial fibrillation

Approved in European Union as Medtronic LINQ-2 ILR for:

• Detection and management of arrhythmia
• Monitoring for atrial fibrillation

Approved in Canada as Medtronic LINQ-2 ILR for:

• Detection and management of arrhythmia
• Monitoring for atrial fibrillation

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

Published Research Related to This Trial

Insertable loop recorders (ILRs) are generally safe devices used for continuous cardiac monitoring, but rare complications can occur, such as the subacute rupture of breast implants after placement.

This case report is the first documented instance of breast implant rupture following ILR insertion, highlighting the need for awareness of potential complications associated with this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unexpected Silicone Breast Implant Rupture After Implantation of Insertable Loop Recorder. Syal, S., Mwansa, V., Chhabra, L.[2018]

Implantable loop recorders are effective diagnostic tools for detecting cardiac arrhythmias without relying on patient compliance, making them a reliable option for continuous monitoring.

These devices use automatic algorithms to preselect arrhythmic events, which are then transmitted via telemonitoring to cardiac specialists, enhancing the efficiency of diagnosis and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implantable ECG monitors]. Jilek, C., Lewalter, T.[2020]

The BioMonitor 2-AF, an implantable loop recorder, demonstrated high P-wave visibility (94.4%) and effective remote monitoring with 100% successful automatic transmissions, indicating its reliability for continuous cardiac monitoring.

No complications related to the ILR were reported, and while some misclassification of episodes occurred in 15.8% of patients, the overall safety and effectiveness of the device were confirmed in this first-in-human study involving 19 patients over a 6-week follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse? Lacour, P., Dang, PL., Huemer, M., et al.[2019]

The Medtronic Reveal LINQTM implantable loop recorder (ILR) was successfully used in 154 patients, allowing for remote monitoring and leading to earlier diagnosis of serious arrhythmias in 64% of cases during an average follow-up of 12.1 months.

While the device was generally safe, with only one case of skin erosion and no infections, there were notable issues with false bradycardia detection in 29% of patients due to undersensing, highlighting a technical challenge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder Medtronic Reveal LINQTM. Maines, M., Zorzi, A., Tomasi, G., et al.[2019]

The BioMonitor 2 implantable loop recorder (ILR) can be implanted quickly and without complications, making it a safe option for long-term cardiac monitoring in patients with unexplained syncope and other conditions.

Initial sensing quality of the BioMonitor 2 improves over time, with R-wave amplitude increasing from 0.84 mV at implantation to 1.02 mV after an average follow-up of 85 days, indicating effective performance in detecting cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BioMonitor 2 insertable cardiac monitor: Clinical experience with a novel implantable cardiac monitor. Reinsch, N., Ruprecht, U., Buchholz, J., et al.[2019]

In a study of 181 patients with unexplained syncope, presyncope, or palpitations, the implantable loop recorder (ILR) was able to provide a diagnostic result in 54.1% of cases, confirming its value in identifying cardiac arrhythmias.

The average time to a diagnostic event was about 11 months, and the ILR was particularly effective for patients with syncope or presyncope, suggesting it should be considered early in the evaluation process for these symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic value of implantable loop recorders in patients with unexplained syncope or palpitations. Radovanović, NN., Pavlović, SU., Kirćanski, B., et al.[2021]

The study involved 125 patients and demonstrated a 100% acute procedural success rate for injectable implantable loop recorder (ILR) placement in an ambulatory care setting, indicating high efficacy of the procedure.

The complication rate was very low, with only 1.6% experiencing subacute complications, suggesting that this method is safe for patients and can improve workflow in electrophysiology labs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injectable loop recorder implantation in an ambulatory setting by advanced practice providers: Analysis of outcomes. Kipp, R., Young, N., Barnett, A., et al.[2018]

Citations

1. medtronic.com medtronic.com/en-us/healthcare-professionals/products/cardiac-rhythm/cardiac-monitoring/insertable-cardiac-monitors/linq-ii-icm.html

LINQ II™ Insertable Cardiac Monitor The LINQ II™ insertable cardiac monitor (ICM) with AccuRhythm™ AI algorithms is used for long-term heart monitoring.

2. news.medtronic.com news.medtronic.com/Medtronic-LINQ-Insertable-Cardiac-Monitors-prove-cost-effective-compared-to-standard-of-care-in-ischemic-stroke-patients-with-suspected-atrial-fibrillation

Medtronic LINQ Insertable Cardiac Monitors prove cost- ... Medtronic LINQ Insertable Cardiac Monitors prove cost-effective compared to standard of care in ischemic stroke patients with suspected atrial ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5917869/

The first case of the Reveal LINQ™ Insertable Cardiac Monitor ... ILR/ICM devices have revolutionized cardiac monitoring and have had a tremendous impact on the aetiological diagnosis and management of unexplained syncope ...

4. medtronic.com medtronic.com/uk-en/patients/treatments-therapies/heart-monitors/our-monitors/linq-ii.html

LINQ II TM Insertable Cardiac Monitoring (ICM) System The LINQ II Insertable Cardiac Monitor (ICM) provides long-term monitoring for suspected arrhythmias and atrial fibrillation.

5. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/insertable-heart-monitors/getting-monitor/linq-ii-icm-system.html

LINQ II ICM System - Getting a Heart Monitor Watch this video to see how the LINQ II™ insertable cardiac monitor (ICM) system works to collect data about your abnormal heartbeats and communicate to your ...

6. medtronic.com medtronic.com/en-us/l/isw/cardiac-monitors-indications-safety-warnings.html

Indications, Safety, & Warnings - Cardiac Monitors The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K200795.pdf

July 3, 2020 Medtronic, Inc. Eric Kalmes Sr. Principal ... The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6545016/

Safety of in-hospital insertable cardiac monitor procedures ... Subcutaneous insertable cardiac monitors (ICMs) continuously record ECG for up to 3 years and are used clinically for the detection of ...