Medtronic has enrolled first subjects in the ALLEVIATE-HF clinical trial, which will assess the ability of its Reveal LINQ Insertable Cardiac Monitor (ICM) in detecting patients at high risk of worsening heart failure.
The LINQ device is designed to notify clinicians if a patient is at high risk for a heart failure episode, enabling physicians to adjust medications to improve patient health. It enables physicians to continuously and wirelessly monitor a patient’s heart for arrhythmia disorders.
The clinicians will be alerted to signs of worsening heart failure by the use of a proprietary algorithm added to the Reveal LINQ system for the study. They will receive the information through nightly transmissions delivered to the Medtronic CareLink Network from patients’ bedside monitors.
ALLEVIATE-HF clinical trial will evaluate whether early information delivered by the LINQ devices enables clinicians to take action before patients’ conditions worsen.
The prospective, randomised, multisite, interventional, investigational device exemption (IDE) study will enrol approximately 300 patients at up to 30 sites across the US. Patients will be followed after a minimum of seven months and for up to three years.
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Medtronic Cardiac and Vascular Group Cardiac Rhythm and Heart Failure division chief medical officer Rob Kowal said: “For two decades, Medtronic has been an innovator in cardiac monitoring, allowing for diagnosis and management in the home rather than the hospital environment.
“Heart failure management is a critical element in extending the capabilities of the LINQ platform beyond arrhythmia management to reach more patients with the right interventions before heart failure progresses. By initiating the ALLEVIATE-HF trial, Medtronic endeavours to help improve how clinicians receive actionable insights to better treat higher-risk patient populations.”
With the commencement of the ALLEVIATE-HF trial, Medtronic is the first to assess the use of an ICM to manage heart failure in a remote setting.
Heart failure affects approximately 6.2 million people in the US and contributes to an estimated 380,000 deaths per year in the country alone.
The condition arises due to the inability of the heart to pump enough blood to meet the body’s needs. It leads to fluid build-up in the legs, lungs and in other tissues throughout the body, leaving patients feeling tired or experiencing shortness of breath.
Earlier this month, Medtronic received the Food and Drug Administration (FDA) approval for the early feasibility study of the Intrepid Transcatheter Tricuspid Valve Replacement system in patients with severe, symptomatic tricuspid regurgitation.