Investigational LUX-Dx ICM Implant for Heart Failure
This study is evaluating whether a device which monitors heart activity may help detect heart attacks.
See full descriptionAbout 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.
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.
Approximate Timelines
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.
Patient Q & A Section
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.