Medtronic has announced the first enrolments in the ALLEVIATE-HF clinical trial which will evaluate the ability of its Reveal LINQ insertable cardiac monitor (ICM) in identifying patients at high-risk of worsening heart failure. The trial will determine if early information provided by the LINQ devices enable clinicians to take action before patients’ conditions worsen. The LINQ device will alert clinicians if a patient is at high risk for a heart failure event, allowing time for a physician to adjust medications to enhance patient health.
The Reveal LINQ ICM allows physicians to continuously and wirelessly monitor a patient’s heart for arrhythmia disorders. With a proprietary algorithm added to the Reveal LINQ system for this study, clinicians will be alerted to signs of worsening heart failure. They will receive the information via nightly transmissions delivered to the Medtronic CareLink network from patients’ bedside monitors. Patient data will be stratified by risk level, providing physicians remote access to patient data and allowing them to intervene earlier than possible without this system.
The first patients were enrolled at Cardiology Associates of North Mississippi, Tupelo, USA by Barry Bertolet, and Florida Heart Center, Port St Lucie, USA by Prasad Chalasani. The trial is a prospective, randomised, multisite, interventional, investigational device exemption (IDE) study that will enroll up to 300 patients at up to 30 sites across the USA. Patients will be followed a minimum of seven months and up to three years. With the commencement of the ALLEVIATE-HF trial, Medtronic is the first to study the use of an ICM to manage heart failure in a remote setting.
“It’s vital that clinicians know about the early warning signs of worsening heart failure, and this study will help us determine if the new LINQ algorithm will identify that information so we can take action,” said Javed Butler, chairman of the Department of Medicine at the University of Mississippi, Oxford, USA and chair of ALLEVIATE-HF Steering Committee. “Remote monitoring may transform treatment and personalize the ongoing management of patients, and we look forward to having more evidence to help physicians proactively manage their patients, even without a face-to-face visit.”
The Reveal LINQ ICM is approximately one-third the size of a AAA battery and is placed just beneath the skin through a small incision of less than 1cm in the upper left side of the chest, using a minimally invasive procedure. The device communicates wirelessly with a patient bedside monitor that uploads device data to the CareLink network; it is MR-conditional, allowing patients to undergo magnetic resonance imaging (MRI), if needed. The remote monitoring feature of the LINQ device could potentially reduce unnecessary in-office visits since physicians have remote access to patient data.
“For two decades, Medtronic has been an innovator in cardiac monitoring, allowing for diagnosis and management in the home rather than the hospital environment,” said Rob Kowal, chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. “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 endeavors to help improve how clinicians receive actionable insights to better treat higher-risk patient populations.”