LUX-Dx ICM Sensor Data Collection for Heart Failure

Recruiting at 77 trial locations

Overseen By Eugene Depasquale, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Disqualifiers: Other active devices, Heart transplant, Amyloidosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4.5 years

525 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect data from a special heart monitor, the LUX-Dx ICM, to improve understanding of heart failure. The device, implanted in the body, tracks heart activity. The trial seeks individuals who have experienced heart failure symptoms, such as shortness of breath or fatigue, and have had a heart issue diagnosis for more than a year. Participants should not have other active electronic devices implanted and must be willing to use a mobile app for monitoring. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future heart failure treatments.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the LUX-Dx ICM device is safe for heart failure patients?

Research has shown that the LUX-Dx Insertable Cardiac Monitor (ICM) is generally well-tolerated by patients. Early studies examined the safety of inserting the device and its effectiveness in remotely monitoring heart rhythms. These studies suggested that the device rarely causes serious side effects. However, patients with the LUX-Dx ICM should avoid certain treatments, such as diathermy (a type of heat therapy), as they could harm the device. Overall, existing evidence supports the safety of the LUX-Dx ICM for monitoring heart conditions, and it is already used in patients at risk for abnormal heart rhythms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LUX-Dx ICM Implant for heart failure because it offers a novel approach to monitoring heart health. Unlike traditional treatments that primarily focus on alleviating symptoms or improving heart function through medication, the LUX-Dx ICM Implant is a small, implantable device that continuously collects detailed heart data. This real-time monitoring capability allows for the early detection of changes in heart function, potentially leading to timely interventions. By offering insights that are not available through standard diagnostics, the LUX-Dx ICM Implant could revolutionize how physicians manage and treat heart failure.

What evidence suggests that the LUX-Dx ICM device is effective for heart failure?

Research shows that the LUX-Dx ICM Implant serves as a tool to monitor heart health. Early results indicate that the device is safe to insert and can be used for remote monitoring and adjustments. This capability might help track heart conditions without frequent hospital visits. Other studies have found that remote monitoring can improve heart health, such as lowering the risk of death. The device's sensors collect information that could help manage heart failure more effectively. ^{2 5 6 7 8}

Who Is on the Research Team?

Scott Solomon, MD

Principal Investigator

Brigham and Women's Hospital

Elaine Wan, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for heart failure patients in NYHA Class II or III. Eligible participants must have specific echocardiography findings and elevated BNP/NT-proBNP levels, a recent hospitalization for heart failure, or unscheduled IV therapy within the last year. They should be willing to use an ICM mobile app and not have any other active electronic medical devices implanted.

Inclusion Criteria

My heart's pumping ability is low, and I've had recent heart failure symptoms or treatment.

I have moderate heart condition symptoms.

Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.

Exclusion Criteria

Patient is currently enrolled in another investigational study (excluding registries) without prior written approval from Boston Scientific.

I have had a heart transplant.

Patient is known to be pregnant at the time of enrollment or plans to become pregnant during study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the investigational LUX-Dx ICM device and data is collected for diagnostic purposes

4.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigational LUX-Dx ICM Implant

Trial Overview The study aims to collect data from Boston Scientific's investigational insertable cardiac monitor (ICM) system called LUX-Dx in patients with heart failure. The focus is on how well the diagnostic sensors work within this new device.

How Is the Trial Designed?

Group I: Treatment Arm Experimental Treatment 1 Intervention

All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

Implantable cardiac monitors (ICMs) can significantly aid in diagnosing and managing arrhythmias in high-risk heart failure patients, particularly those with a left ventricular ejection fraction (LVEF) greater than 35%, who are not candidates for pacemakers or defibrillators.

The use of telemonitoring with ICMs may improve patient prognosis and quality of life by providing continuous monitoring and timely management of arrhythmias, which are common in this population and can negatively affect cognitive function and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implantable cardiac monitor in heart failure patient: a possible new indication? Cicogna, F., Lanza, O., Monzo, L., et al.[2023]

The Heart Failure Collaboratory developed a streamlined case report form (CRF) for heart failure clinical trials, reducing the number of data items from 176 to 75 baseline items and 6 events, which aims to improve trial efficiency and reduce administrative burdens.

This new consensus CRF, created with input from various stakeholders including patients and the FDA, is designed to enhance data compatibility across trials, ultimately improving the integrity of evidence collected in heart failure device development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. Psotka, MA., Fiuzat, M., Carson, PE., et al.[2020]

The Reveal LINQ™ insertable cardiac monitor (ICM) has a very low complication rate, with only 0.63% of patients experiencing adverse events (AEs) requiring explantation during a median follow-up of 499 days.

Patients implanted in outpatient procedure rooms had a higher rate of infections compared to those in electrophysiology laboratories, but overall, the ICM can be safely implanted in both settings with minimal risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study. Diederichsen, SZ., Haugan, KJ., Højberg, S., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9849434/

Preliminary results from the LUX‐Dx insertable cardiac ... We present preliminary results from the trial focusing on the safety of ICM insertion, remote monitoring rates, and the feasibility of remote programming.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04790344

LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart ... The primary objective of this study is to collect physiological measurement data and heart failure (HF) event data that will be used to design and develop ...

3. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/lux-dx-icm/Clinical%20Compendium%20LUX-Dx%20II.II%2B.pdf

LUX-Dx ICM Systems The LUX-Dx TRENDS clinical trial will collect sensor and heart failure event data that will be used in the development of new insertable cardiac monitoring ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12296957/

Subcutaneous sensors for monitoring congestion and to ... For instance, the IN-TIME Trial demonstrated improved clinical outcomes, including reduced mortality, through multiparameter remote monitoring [ ...

5. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/Rhythm%20Management/portfolio-group/lux-dx-icm/Clinical-Cardiology-2022-Preliminary-results-LUXDx.pdf

Preliminary results from the LUX‐Dx insertable cardiac ... Here, we present preliminary results from the trial focusing on the safety of ICM insertion, remote monitoring rates, and the feasibility of remote programming.

6. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/cardiac-monitors/lux-dx--insertable-cardiac-monitor-icm-system-/fp00000496/lux-dx-indications-safety-warnings.html

Indications, safety, and warnings The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm.

7. bostonscientific.com bostonscientific.com/en-US/products/cardiac-monitors/LUX-Dx-ICM-System-ii/LUX-Dx-ICM-II-clinician-brief-summary.html

LUX-Dx™ Insertable Cardiac Monitor System Indications, ... Do not expose a patient with an ICM system to diathermy. The interaction of diathermy therapy with an insertable cardiac monitor can damage the device and cause ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K231328.pdf

LUX-Dx II (M302) - accessdata.fda.gov The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-. ECG). The recorded S-ECG is ...