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Diagnostic Sensor

LUX-Dx ICM Sensor Data Collection for Heart Failure

N/A
Recruiting
Led By Scott Solomon, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is currently in NYHA Class II or III.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion of approximately 4.5 year
Awards & highlights

Study Summary

This trial is designed to study the feasibility of collecting sensor data from insertable cardiac monitor systems.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks of implanting a cardiac monitor may include infection at the insertion site, bleeding, pain or discomfort, allergic reaction to materials used in the device, and potential device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate heart condition symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion of approximately 4.5 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion of approximately 4.5 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for heart failure include ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. ACE inhibitors work by relaxing blood vessels and reducing the workload on the heart. Beta-blockers slow the heart rate and decrease blood pressure, improving heart function. Diuretics help remove excess fluid from the body, reducing the strain on the heart. Aldosterone antagonists prevent fluid retention and reduce the risk of hospitalization. These treatments are crucial for managing heart failure symptoms and improving quality of life. Continuous monitoring and recording of cardiac electrical activity, as studied in Insertable Cardiac Monitor Systems, can help tailor these treatments by providing real-time data on heart function, allowing for timely adjustments and better management of the condition.
[Device-based remote monitoring : Current evidence].Utility of Consumer Physical Activity Trackers as an Intervention Tool in Cardiovascular Disease Prevention and Treatment.

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
723 Previous Clinical Trials
933,368 Total Patients Enrolled
72 Trials studying Heart Failure
42,630 Patients Enrolled for Heart Failure
Scott Solomon, MDPrincipal InvestigatorBrigham and Women's Hospital
6 Previous Clinical Trials
19,727 Total Patients Enrolled
Elaine Wan, MDPrincipal InvestigatorColumbia University

Media Library

Investigational LUX-Dx ICM Implant (Diagnostic Sensor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04790344 — N/A
~189 spots leftby May 2026
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