CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 525 enrolled
Drug / intervention
office setting +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02395536
NCT02395536N/ACompleted

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

Medtronic Cardiac Rhythm and Heart Failure·interventional·Posted Mar 23, 2015·Updated Oct 4, 2017

In Brief

A clinical study evaluating office setting and hosptial setting for Arrhythmia. Completed, enrolled 525 participants across 27 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArrhythmia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 23, 2015
Enrollment StartMar 30, 2015
Primary CompletionMay 31, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.3 years ago

Interventions

office settingother

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

hosptial settingother

A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.