CLINICAL TRIAL

Investigational LUX-Dx ICM Implant for Heart Failure

Recruiting · 18+ · All Sexes · Mobile, AL

This study is evaluating whether a device which monitors heart activity may help detect heart attacks.

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About the trial for Heart Failure

Treatment Groups

This trial involves 2 different treatments. Investigational LUX-Dx ICM Implant is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Investigational LUX-Dx ICM Implant
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patient is currently in NYHA Class II or III.
ONE (1) of the following echocardiography findings: LA width (diameter) >3.8 cm, LA length >5.0 cm, LA area >20 cm2, LA volume >55 ml, LA volume index >29 ml/m2, LVH defined by septal thickness or posterior wall thickness of >1.1 cm
Patient is willing to be monitored in LATITUDE Clarity and use the ICM patient mobile app.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Through study completion of approximately 4.5 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion of approximately 4.5 year.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Investigational LUX-Dx ICM Implant will improve 1 primary outcome in patients with Heart Failure. Measurement will happen over the course of Through study completion of approximately 4.5 year.

Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC.
THROUGH STUDY COMPLETION OF APPROXIMATELY 4.5 YEAR
Heart Failure (HF) event is defined as: HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy. HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for heart failure?

Almost one fifth of patients with heart failure would desire to try lifestyle or dietary modifications to improve their health status. Most patients with heart failure receive the standard medical therapy for heart failure. Beta-blockers are the most common treatment for heart failure.

Anonymous Patient Answer

Can heart failure be cured?

It is concluded that the hypothesis that heart failure can be cured by pharmacological management is unsupported by both randomized controlled trial and meta-analysis of current literature.

Anonymous Patient Answer

What are the signs of heart failure?

Many symptoms of heart failure have been described, but there are still unanswered questions and research needs. For a symptom to be universally acknowledged as a clinical sign of heart failure, it must have >50% sensitivity; this is currently uncertain. It is likely that there are many symptoms associated with heart failure, but many of their prevalence and clinical utility are unknown. Furthermore, the use of the terminology'symptoms' from a heart failure viewpoint needs reassessment and re-examination.

Anonymous Patient Answer

What is heart failure?

Failure of the heart and lungs to pump blood efficiently due to a multitude of causes is a common syndrome that leads to a variety of different symptoms, signs and complications, most notably breathlessness and a reduced ability to exercise. Failure of the ventricles of the heart to do their job leads to reduced ventricular stroke volumes, reduced vascular resistance and lowered oxygen transport to the tissues. It is a chronic condition that is often under diagnosed and under treated. There are many risk factors for the development of heart failure, the ageing population is a particular risk factor of heart failure as they have been in the process of ageing for many years. This condition is the focus of the majority of cardiac interventions to treat.

Anonymous Patient Answer

What causes heart failure?

A number of heart valve problems, including endocarditis, can reduce the blood flow through the heart and therefore heart muscle may be deprived of blood and eventually fail. Cardiac muscle diseases include hypertrophic cardiomyopathy, dilated cardiomyopathy, and cardiomyopathy associated with congenital heart disease in which the defect compromises the functioning of valves of the heart. Diabetes may also contribute to heart failure and blood pressure of the heart.\n

Anonymous Patient Answer

How many people get heart failure a year in the United States?

The prevalence of heart failure declines with age. While heart failure affects about 1% of those 65 years of age and older in the United States, it affects more than 7% of those age 65 years and older, and 20% of those age 70 years and older. While this is a dramatic increase, the proportions of women and blacks have declined over the last 15 years, suggesting more women are dying of the illness than it was a generation ago.

Anonymous Patient Answer

What are the latest developments in investigational lux-dx icm implant for therapeutic use?

These new ICMs have an excellent safety record and have proven efficacy in the treatment of HF. The ICM-S system has the potential to further expand the spectrum of treatment for patients with advanced HF, including younger patients and those with preserved heart function. Additional studies are needed to further characterize the efficacy and utility of newer ICMs. Clinicaltrials.

Anonymous Patient Answer

What is the latest research for heart failure?

There is a good amount of research on various interventions for heart failure. Most studies are conducted in well-resourced hospital settings. It is important to be aware of the quality of research, the quality of data collected, and the quality of the interventions researched.

Anonymous Patient Answer

Does investigational lux-dx icm implant improve quality of life for those with heart failure?

The lux-dx ICM was associated with an important improvement in symptoms of HF, HRQoL, and QoL when compared with conventional management with biventricular pacemakers/defibrillators, particularly when coupled with optimal therapy for concomitant CHF.

Anonymous Patient Answer

What does investigational lux-dx icm implant usually treat?

The investigational device is used to treat patients either awaiting or whose current standard treatment is not successful. The investigational device has demonstrated clinical effectiveness for patients with life threatening ventricular tachycardia (VTs), advanced atrial fibrillation (AFs), and chronic ventricular dysfunction. The investigational device was also shown to reduce the rate and size of life-threatening, inpatient VT episodes in patients with sustained VT episodes during standard current treatment. When compared to clinical experience with other ventricular implantable devices, the investigational device demonstrates a very low rate of system-related complications compared to other ventricular devices.

Anonymous Patient Answer

How does investigational lux-dx icm implant work?

The investigational device works via the generation of a local TNFα response after implantation which causes chronic lymphocytic inflammation and cell proliferation resulting in fibrosis, and subsequent fibrous scar formation. This provides the mechanistic basis for the improvement in ejection fraction in patients. A larger trial using this device is underway.

Anonymous Patient Answer

What is investigational lux-dx icm implant?

For the first time, the investigational device and related implant have been marketed by the company. The main function of the investigational device is intended for the treatment of cardiac arrest, especially as a life-saving device. The investigational devices will be manufactured by a company that has been producing artificial hearts for many years. The functional principle of this device is, that the heart is stimulated to start the pumping process with a slight electrical pulse supplied by the device or a hand-pumped ventilator. This stimulation of the ventricle is triggered by a sensor located on the skin of the patient or the bedside monitoring device in the case of bedside monitors.

Anonymous Patient Answer
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