Implanted Loop Recorder for Arrhythmia Detection

Recruiting in Palo Alto (17 mi)

Overseen by Haisam Ismail, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwell Health

Must be taking: BTK inhibitors

Must not be taking: Anti-arrhythmics, Anticoagulants

Disqualifiers: Arrhythmia, CVA, TIA, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Medtronic LINQ-2 Insertable Cardiac Monitor (ILR)?

Research shows that implantable loop recorders like the Medtronic LINQ-2 are effective for long-term heart monitoring, helping to diagnose conditions like arrhythmias (irregular heartbeats) and unexplained fainting. They can be safely inserted outside of traditional surgical settings, making them more accessible for patients. ^{1 2 3 4 5}

Is the Medtronic LINQ-2 Insertable Cardiac Monitor safe for humans?

The Medtronic LINQ-2 Insertable Cardiac Monitor is generally considered safe for humans, with rare complications reported. One study noted that it can be safely inserted outside of a traditional surgical setting, and another reported a rare case of breast implant rupture after its placement. ^{1 2 3 4 6}

How is the Medtronic LINQ-2 Insertable Cardiac Monitor treatment different from other treatments for arrhythmia detection?

The Medtronic LINQ-2 Insertable Cardiac Monitor is unique because it is a small device implanted under the skin that continuously monitors heart rhythms for up to three years and can be remotely monitored, unlike traditional methods that require frequent hospital visits. ^{1 2 4 5 7}

Research Team

Robert S Copeland-Halperin, MD

Principal Investigator

Northwell Health

Haisam Ismail, MD

Principal Investigator

Northwell Health

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Medtronic LINQ-2 Insertable Cardiac Monitor (ILR) (Device)

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.

Participant Groups

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 Canada for the following indications:

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+

Michael Dowling

Northwell Health

Chief Executive Officer since 2002

Bachelor's and Master's degrees from University College Cork, Ireland

Dr. David Battinelli

Northwell Health

Chief Medical Officer since 2022

MD from Georgetown University School of Medicine

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical impact, safety, and accuracy of the remotely monitored implantable loop recorder Medtronic Reveal LINQTM. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The BioMonitor 2 insertable cardiac monitor: Clinical experience with a novel implantable cardiac monitor. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Injectable loop recorder implantation in an ambulatory setting by advanced practice providers: Analysis of outcomes. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Performance of the New BioMonitor 2-AF Insertable Cardiac Monitoring System: Can Better be Worse? [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Diagnostic value of implantable loop recorders in patients with unexplained syncope or palpitations. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Unexpected Silicone Breast Implant Rupture After Implantation of Insertable Loop Recorder. [2018]

7. Germany pubmed.ncbi.nlm.nih.gov

[Implantable ECG monitors]. [2020]