Implantable Loop Recorder for Single Ventricle Heart Defects

Overseen By Olivia Rossi

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Boston Children's Hospital

Disqualifiers: Prematurity, Low birth weight, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a small device called an implantable loop recorder, which monitors heart rhythms. The goal is to determine its safety and effectiveness for newborns with single ventricle heart defects after their first heart surgery. It continuously tracks heart rate and irregularities during a critical recovery period. The trial seeks newborns who have undergone their first stage of heart surgery for single ventricle defects within their first month of life. As an Early Phase 1 trial, this research aims to understand how the device functions in newborns, offering participants the opportunity to be among the first to benefit from this innovative monitoring technology.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this implantable loop recorder is safe for newborns with single ventricle heart defects?

Research has shown that implantable loop recorders, such as the LUX-Dx™, are generally safe for people. These small devices are placed under the skin in the chest area and continuously monitor the heartbeat for up to three years.

In previous studies, some patients experienced minor heart rhythm issues. Specifically, about 17.3% had first-degree atrioventricular block, 12.9% had a delay in the heart's electrical signals on the right side (right bundle branch block), and 6.7% had a delay on the left side (left bundle branch block).

The device is designed to fit comfortably and securely and has been used in various heart conditions before. Although this trial is in an early phase, meaning safety data is still being collected, implantable loop recorders have a history of safe use in other situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which typically involves medications and surgeries to manage single ventricle heart defects, the Implantable Loop Recorder offers a unique approach by continuously monitoring heart rhythms. This tiny device is implanted under the skin, providing real-time data on heart activity without the need for frequent hospital visits. Researchers are excited about this treatment because it has the potential to catch irregular heartbeats early, offering a more proactive way to manage heart health and personalize treatment plans for patients with single ventricle defects.

What evidence suggests that this implantable loop recorder is effective for single ventricle heart defects?

Research shows that implantable loop recorders (ILRs) effectively track heart rhythms in people with heart conditions. In those with congenital heart disease, ILRs helped doctors diagnose heart rhythm issues in 71% of cases. Specifically, they identified problems with the heart's rhythm. Another study found that ILRs detected issues like electrical signal problems in about 20% of patients. In children, ILRs have successfully monitored heart conditions, providing crucial information about heart activity. Although these studies did not specifically examine single ventricle heart defects, the findings suggest that ILRs can help doctors monitor heart rhythms and detect problems early. ^{2 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for newborns with a heart condition called single ventricle physiology who are undergoing their first heart surgery within the first month of life. Babies born prematurely (before 36 weeks) or weighing less than 2.5 kg, those with certain other treatments like ductus arteriosus stenting, and those with devices affected by magnets can't participate.

Inclusion Criteria

My baby is having a heart surgery within the first month of life due to a single ventricle condition.

Exclusion Criteria

Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices

Clinical team does not think that the patient is a good candidate

I have undergone a specific heart procedure for congenital heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Implantable loop recorder (LUX-DX™) is placed at the time of chest closure following stage 1 palliation

1 week

1 visit (in-person)

Interstage Monitoring

Continuous measurement of heart rate and arrhythmia using the implantable loop recorder during the interstage period

4-6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Implantable Loop Recorder

Trial Overview The study tests the safety and usefulness of an implantable loop recorder device named LUX-Dx™ in these babies. It's placed under the skin during chest surgery to continuously monitor heart rate and detect irregular heartbeats over a period ranging from six months up to three years.

Implantable Loop Recorder is already approved in European Union, United States for the following indications:

Approved in European Union as LUX-Dx for:

• Atrial fibrillation
• Cryptogenic stroke
• Syncope

Approved in United States as LUX-Dx for:

• Cardiac arrhythmias
• Atrial fibrillation
• Cryptogenic stroke
• Syncope

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a study of 743 patients with implantable loop recorders (ILRs), those in secondary hospitals had a higher final diagnosis rate (55.4%) compared to those in tertiary hospitals (30.8%), despite similar clinical characteristics.

While tertiary hospitals conducted more electrophysiologic studies and tilt table tests, the safety profile was comparable between both groups, with no significant differences in rates of deaths or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the yield of the implantable loop recorder between secondary and tertiary centers. Lacunza-Ruiz, FJ., Moya-Mitjans, A., Martínez-Alday, J., et al.[2015]

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 Sleuth implantable loop recorder (ILR) can be effectively implanted at both midclavicular and inframammary sites without the need for preimplant ECG mapping, simplifying the procedure for patients.

Over a 1-year follow-up with 32 patients, the ILR demonstrated good sensing capabilities, with significant improvements in R-wave amplitudes observed by 6 months, indicating reliable performance in monitoring unexplained syncope.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensing performance of a new wireless implantable loop recorder: a 12-month follow up study. Jacob, S., Kommuri, NV., Zalawadiya, SK., et al.[2019]

The implantable loop recorder (ILR) is an effective diagnostic tool for monitoring heart activity over extended periods, particularly for detecting arrhythmias.

Beyond arrhythmias, the ILR can also help identify repolarization disorders in patients with myocardial ischemia, suggesting its broader potential in cardiac diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case of variant angina associated with syncope detected by an implantable loop recorder. Deng, Y., Wan, X., Su, X., et al.[2021]

In a study of 263 patients over 4 years, implantable loop recorders (ILRs) showed the highest diagnostic yield for atrial fibrillation (AF), palpitations, and ventricular arrhythmias, with yields of 65%, 60%, and 70% respectively.

The diagnostic yield for syncope was significantly lower at 28%, which is about half of what previous studies reported, indicating a need for further research to optimize ILR implantation guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnostic yield of implantable loop recorders stratified by indication: "real-world" use in a large academic hospital. Smith, A., Perdue, M., Vojnika, J., et al.[2021]

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 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]

In a study involving 743 patients who received implantable loop recorders (ILRs) for diagnosing arrhythmias, recurrent syncope was the most common reason for implantation, accounting for 76.4% of cases.

The ILR successfully provided a final diagnosis for about one-third of patients, with syncope due to bradyarrhythmia being the most frequent diagnosis, indicating its effectiveness in real-world clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable loop recorder allows an etiologic diagnosis in one-third of patients. Results of the Spanish reveal registry. Lacunza-Ruiz, FJ., Moya-Mitjans, A., Martínez-Alday, J., et al.[2019]

Citations

1. withpower.com withpower.com/trial/early-phase-1-univentricular-heart-2-2023-8cac0?condition=Single+Ventricle+Heart&overallStatus=Recruiting&hasNoPlacebo=false

Implantable Loop Recorder for Single Ventricle Heart Defects 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19153088/

Single-centre use of implantable loop recorders in patients ... Implantable loop recorders lead to a positive or negative arrhythmic diagnosis following explantation in 71% of patients with congenital heart disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5129687/

Efficacy And Safety Of Implantable Loop Recorder In patients with syncope atrioventricular conduction disturbance was demonstrated in 19.6%, sinus node dysfunction in 16.1%, paroxysmal supra-ventricular ...

4. emedicine.medscape.com emedicine.medscape.com/article/1920236-overview

Implantable Loop Recorder (Insertable Cardiac Monitor) The device is typically implanted in the left parasternal region and is capable of storing ECG data automatically in response to a significant ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914921007207

Outcomes of Implantable Loop Monitoring in Patients <21 ... We sought to evaluate the use, efficacy and outcomes of implantable loop recorders (ILR) in pediatrics. We conducted a retrospective study of ...

6. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/cardiac-monitors/lux-dx-iiplus-insertable-cardiac-monitor-icm-system/fp90000113.html

LUX-Dx II+™ Insertable Cardiac Monitor (ICM) System LUX-Dx II and LUX-Dx II+ Insertable Cardiac Monitor Systems indications, safety, and warnings.

7. mayoclinic.org mayoclinic.org/tests-procedures/implantable-loop-recorder/about/pac-20579708

Implantable loop recorder: A heart monitoring device An implantable loop recorder is a very small device that continuously checks the heartbeat. It stays in place under the skin of the chest for up to three years.