Reveal LINQ™ In-Office 2 (RIO2) Study International (RIO2)

Reveal LINQ™ In-Office 2 (RIO2) International Study

The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Other: Out of cathlab insertion

Detailed Description

The traditional location of the LINQ™ insertion procedure is the catheterization laboratory, electrophysiology laboratory, or operating room. The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor (ICM)
• Patient is at least 18 years of age or older if required by local regulations
• Patient is willing to undergo ICM insertion procedure outside of the cathlab, operating room, or EP lab setting with only local anesthetic
• Patient is willing and able to provide consent and authorize the use and disclosure of health information
• Patient is willing and able to comply with the elements of the clinical investigation plan including the required follow-up

Exclusion Criteria:

• Patient has unusual thoracic anatomy or scarring at the insertion site which may adversely affect the success of the insertion procedure
• Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
• Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
• Patient requires hemodialysis
• Patient with active malignancy or history of chemotherapy or radiation treatment
• Patient has had a recent (within 30 days) or an active infection including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
• Patient has had major surgery (in the past 6 months) Patient has undergone a procedure which required central venous or intra-arterial access (e.g. AF/VT ablation, EP study, coronary angiography) within the last 3 months or is scheduled for such a procedure while enrolled in the study
• Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months
• Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
• Patient requires conscious or moderate sedation to receive LINQ™
• Patient already has an inserted or implanted loop recorder
• Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
• Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
• Patient's life expectancy is less than 6 months
• Patient is legally incapable of giving consent
• Patient is pregnant* *Note: Possible pregnancy will be assessed by the physician asking the patient; a pregnancy test is not required

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Out of CathLab setting; Out of cathlab insertion	Other: Out of cathlab insertion; Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Untoward Events	An untoward event is a composite endpoint defined as a LINQTM or LINQTM insertion procedure related complication OR an unsuccessful LINQTM insertion procedure, where a LINQTM or LINQTM insertion procedure related complication is defined as an adverse event related to the LINQTM or a LINQTM insertion procedure resulting in: Death; Termination of significant device function; Invasive intervention (e.g. includes LINQTM revision/explant for reasons other than diagnosis of underlying condition, intravenous drug administration)	3 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Chair: RIO2 Clinical Study Specialist, Medtronic

Publications and helpful links

General Publications

• Sanders P, Piorkowski C, Kragten JA, Goode GK, Raj SR, Dinh T, Sohail MR, Anand R, Moya-Mitjans A, Franco N, Stromberg K, Rogers JD. Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study. BMC Cardiovasc Disord. 2019 May 31;19(1):132. doi: 10.1186/s12872-019-1106-3.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 22, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 9, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: RIO2 International

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO