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".

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".

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

Participants with Reveal LINQ Insertion Attempt

All adverse events that were Reveal LINQ related, Reveal LINQ procedure related including any infections potentially resulting from the LINQ device or procedure as well as all serious events regardless of their relationship to the LINQ device or procedure were collected.

An independent clinical events committee comprised of independent physicians who were not sponsor employees or study investigators adjudicated each reported event for its relationship to the Reveal LINQ system or procedure. All adverse event summaries are based on the clinical events committee's classification.

This was a single arm study