What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that involve continuous monitoring and recording of cardiac electrical activity. Notably, insertable cardiac monitors (ICMs) like the ones being studied in the LUX-Dx TRENDS trial are designed to provide continuous monitoring of heart rhythms, which can be crucial for managing heart failure. Additionally, drugs such as beta-blockers (e.g., metoprolol, carvedilol) and ACE inhibitors (e.g., enalapril, lisinopril) have been approved for heart failure treatment, focusing on improving heart function and reducing symptoms. These treatments, along with advanced monitoring devices, play a significant role in the comprehensive management of heart failure.

What other types of research exist?

Promising alternatives to Insertable Cardiac Monitor Systems for heart failure patients include advanced wearable devices such as wearable cardioverter-defibrillators, which provide continuous monitoring and defibrillation capabilities. Additionally, modern pacemakers with enhanced diagnostic features and non-invasive monitoring systems using high-resolution ECG patches are emerging as viable options. These technologies offer continuous monitoring, improved patient comfort, and reliable data collection.

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Diagnostic Sensor

LUX-Dx ICM Sensor Data Collection for Heart Failure

Q: What side effects are associated with this type of intervention?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. Known side effects of these medications can include cough, elevated potassium levels, kidney dysfunction, dizziness, and increased urination. For treatments involving continuous monitoring and recording of cardiac electrical activity, such as insertable cardiac monitor systems, potential side effects may include infection at the insertion site, device malfunction, and discomfort. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

N/A

Waitlist Available

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

Must not have

Patient has undergone a heart transplant.

Patient is diagnosed with amyloidosis or hypertrophic cardiomyopathy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion of approximately 4.5 year

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a heart transplant.

Select...

I have been diagnosed with amyloidosis or hypertrophic cardiomyopathy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion of approximately 4.5 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met

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.