LUX-Dx ICM Sensor Data Collection for Heart Failure

Recruiting at 76 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

Trial Summary

What is the purpose of this trial?

This trial aims to collect data from small devices placed under the skin that monitor heart activity. The focus is on patients with heart failure to gather information that can help create better diagnostic tools. The data collected will be compared with clinical tests and heart failure events to improve monitoring systems.

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 data supports the effectiveness of the LUX-Dx ICM Implant treatment for heart failure?

Research shows that implantable cardiac monitors (ICMs) can help manage heart failure by detecting early signs of worsening conditions, which allows for timely medical interventions and reduces hospitalizations. Additionally, ICMs have been used to monitor heart rhythms and identify risks in heart failure patients, potentially improving their quality of life and prognosis. ^{1 2 3 4 5}

Is the LUX-Dx ICM Implant safe for humans?

The LOOP study investigated complications after implanting new-generation insertable cardiac monitors (ICMs) and found that while the procedure is minimally invasive, there is limited experience with potential complications. This suggests that while generally considered safe, there may still be some risks involved. ^{1 5 6 7 8}

How is the LUX-Dx ICM Implant treatment different from other heart failure treatments?

The LUX-Dx ICM Implant is unique because it continuously monitors heart function by measuring intracardiac pressures and hemodynamics (blood flow dynamics) in real-time, allowing for precise adjustments in therapy to improve patient outcomes. Unlike traditional treatments that rely on symptoms or periodic tests, this implant provides ongoing data to help prevent hospitalizations by detecting early signs of heart failure worsening. ^{1 4 9 10 11}

Research Team

Scott Solomon, MD

Principal Investigator

Brigham and Women's Hospital

Elaine Wan, MD

Principal Investigator

Columbia University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

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

Remote Left Ventricular Hemodynamic Monitoring Using a Novel Intracardiac Sensor. [2019]

2. England pubmed.ncbi.nlm.nih.gov

The implantable cardiac monitor in heart failure patient: a possible new indication? [2023]

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

A Novel Heart Failure Diagnostic Risk Score Using a Minimally Invasive Subcutaneous Insertable Cardiac Monitor. [2023]

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

Assessing acute ventricular volume changes by intracardiac impedance in a chronic heart failure animal model. [2019]

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

Review of advanced heart failure device diagnostics examined in clinical trials and the potential benefit from monitoring capabilities. [2013]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Complications after implantation of a new-generation insertable cardiac monitor: Results from the LOOP study. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Multiparameter diagnostic sensor measurements during clinically stable periods and worsening heart failure in ambulatory patients. [2021]

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

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. [2020]

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

Implantable hemodynamic monitoring devices in heart failure. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Estimating changes in cardiac output using an implanted hemodynamic monitor in heart failure patients. [2010]

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

Ongoing right ventricular hemodynamics in heart failure: clinical value of measurements derived from an implantable monitoring system. [2022]