ALLEVIATE-HF trial will determine the capability of LINQ ICM device in helping clinicians act before a patient’s condition gets worse
Medtronic enrols first patients in ALLEVIATE-HF trial. (Credit: Medtronic.)
Medtronic has enrolled first patients in the ALLEVIATE-HF clinical trial to evaluate its Reveal LINQ Insertable Cardiac Monitor (ICM) in identifying patients at high-risk of worsening heart failure.
The ALLEVIATE-HF clinical trial is a randomised, multicentre, interventional, investigational device exemption (IDE) study, in around 300 patients at 30 sites across the US.
The patients enrolled in the trial will be followed a minimum of seven months and up to three years.
The clinical trial is aimed at determining the capability of LINQ ICM device in providing early information to help clinicians act before a patient’s condition gets worse.
In the clinical study, an algorithm is added to the Reveal LINQ system to enable clinicians receive alerts on signs of worsening heart failure, through nightly transmissions delivered to the Medtronic CareLink Network from the patients’ bedside monitors.
Medtronic 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 endeavors to help improve how clinicians receive actionable insights to better treat higher-risk patient populations.”
Reveal LINQ ICM device allows continuous and wireless monitoring of patient’s heart
The medical device maker has designed Reveal LINQ ICM device to alert clinicians if a patient is at high risk for heart failure, and allows physicians to prescribe medications that improve patient health.
The device allows continuous and wireless monitoring of patient’s heart for arrhythmia disorders.
Approximately one-third the size of a battery, the device is placed below the skin through a small, less than 1 cm incision in the upper left side of the chest, through a minimally invasive procedure.
The remote monitoring feature of the device is said to reduce the unnecessary in-office visits.
ALLEVIATE-HF steering committee chair Javed Butler said: “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.
“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.”