LUX-Dx ICM Sensor Data Collection for Heart Failure
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.12345
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.15678
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.1491011
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the investigational LUX-Dx ICM device and data is collected for diagnostic purposes
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Investigational LUX-Dx ICM Implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
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