Medtronic has started a study to determine the safety and effectiveness of 'in-office' insertion of its Reveal LINQ miniature cardiac monitor.
Enrolling 540 patients in 30 centres across the US, the Reveal LINQ In-Office 2 (RIO 2) study aims to determine the insertion procedure, if moved to an office setting, is as safe as procedures performed in a traditional hospital setting, such as an operating room, cardiac catheterisation laboratory or electrophysiology laboratory.
During the two-arm, prospective, un-blinded study, patients will be randomised 1:1 to either receive the cardiac monitor in an office setting or in a hospital setting, and will be monitored for three months and evaluated for procedure and device-related complications, and also for procedure time and resources required to perform the procedure.
Medtronic Cardiac Rhythm and Heart Failure division Diagnostics business vice-president Nina Goodheart said: "Physicians have embraced Reveal LINQ ICM for its ease of use, and moving the insertion procedure to the office setting has the potential to improve patient access to cardiac monitoring, while enhancing the overall patient experience."
California-based Scripps Clinic cardiologist John Rogers said: "In-office procedures have the potential to help patients and reduce costs to the healthcare system."
The study is also enrolling 150 patients in 15 centres across Europe, Australia and Canada, with an aim to examine clinical evidence to support moving the LINQ insertion procedure from the traditional hospital setting to new locations within the hospital, or 'out-of-lab.'
Approximately one-third of the size of an AAA battery, Reveal LINQ is a latest generation insertable cardiac monitor, and is placed under the skin of the chest using a minimally invasive insertion procedure and enables physicians to continuously and wirelessly monitor a patient's heart through the Carelink Network for up to three years.
The system was designed for patients who experience symptoms such as dizziness, palpitation, syncope (fainting) and chest pain that may suggest a cardiac arrhythmia and for patients at increased risk of cardiac arrhythmias.