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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 191

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Out of CathLab setting	Out of cathlab insertion	Out of cathlab insertion

Primary Outcome Measures

Name	Time	Method
Number of Participants With Untoward Events	3 months	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)

Secondary Outcome Measures