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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Arrhythmia

Intervention / Treatment
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* Other: Out of cathlab insertion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |