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

Trial Summary

What is the purpose of this trial?

The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period. An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.

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 data supports the effectiveness of the treatment Implantable Loop Recorder for Single Ventricle Heart Defects?

Implantable loop recorders (ILRs) have been shown to be effective in monitoring heart rhythms in patients with unexplained fainting or palpitations, providing valuable diagnostic information. They are safe, can be used outside specialized labs, and have a high success rate in identifying heart rhythm issues, which suggests they could be beneficial for monitoring heart conditions like single ventricle heart defects. ^{1 2 3 4 5}

Is the implantable loop recorder safe for humans?

The implantable loop recorder (ILR) is generally considered safe for humans, as studies have shown it can be easily used in various hospital settings and is effective for long-term heart monitoring. ^{1 2 4 6 7}

How is the Implantable Loop Recorder treatment different from other treatments for single ventricle heart defects?

The Implantable Loop Recorder (ILR) is unique because it is a small device implanted under the skin to continuously monitor the heart's electrical activity over a long period, which helps in diagnosing irregular heart rhythms. Unlike other treatments that may focus on immediate symptom management, the ILR provides ongoing data that can help doctors understand and manage heart conditions more effectively. ^{1 2 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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+

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]

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]

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 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 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 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 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]

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]

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

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

3. Netherlands pubmed.ncbi.nlm.nih.gov

The diagnostic yield of implantable loop recorders stratified by indication: "real-world" use in a large academic hospital. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

Differences in the yield of the implantable loop recorder between secondary and tertiary centers. [2015]

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

Sensing performance of a new wireless implantable loop recorder: a 12-month follow up study. [2019]

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

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

7. Japan pubmed.ncbi.nlm.nih.gov

Implantable loop recorder allows an etiologic diagnosis in one-third of patients. Results of the Spanish reveal registry. [2019]

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

A case of variant angina associated with syncope detected by an implantable loop recorder. [2021]