NCT02395536

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 525 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Arrhythmia

Interventions

Type	Name	Description
OTHER	office setting	An office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not including ambulatory surgical centers
OTHER	hosptial setting	A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.

Timeline

• Start date: 2015-03-30
• Primary completion: 2016-05-31
• Completion: 2016-05-31
• First posted: 2015-03-23
• Last updated: 2017-10-04
• Results posted: 2017-10-04

Locations

27 sites across 1 country: United States