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

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".

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