Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States — RIO 2  

Arrhythmia Clinical Trial

Official title: Reveal LINQ™ In-Office 2 (RIO 2) Study United States

Status Completed

Clinical Trial Summary

The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).

Clinical Trial Description

RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. The primary objective for RIO 2 will be assessed by randomizing subjects to receive their LINQ™ insertion in the office setting or in the traditional hospital environment. Moving the LINQ™ insertion procedure to the office setting is not expected to decrease the complication rate compared to in hospital insertion procedures, however, moving the LINQ™ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system. ;

Related Conditions & MeSH terms

• Arrhythmia

• NCT number: NCT02395536
• Study type: Interventional
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Status: Completed
• Phase: N/A
• Start date: March 30, 2015
• Completion date: May 31, 2016