Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States

Study Overview
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Brief Summary
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The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).

Detailed Description
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RIO 2 is a two arm, randomized, prospective, un-blinded, multicenter, non-significant risk study. The primary objective for RIO 2 will be assessed by randomizing subjects to receive their LINQ™ insertion in the office setting or in the traditional hospital environment. Moving the LINQ™ insertion procedure to the office setting is not expected to decrease the complication rate compared to in hospital insertion procedures, however, moving the LINQ™ insertion procedure out of the traditional hospital setting may benefit the patient and reduce the burden to the healthcare system.

Official Title
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Reveal LINQ™ In-Office 2 (RIO 2) Study United States

Conditions
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Arrhythmia

Intervention / Treatment
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* Other: office setting
* Other: hosptial setting


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 Patient is 18 years of age or older Patient is willing to undergo ICM insertion procedure outside of the cath lab, 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 protocol including the required follow-up Exclusion Criteria: Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant 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 intraarterial access (e.g. AF/VT ablation, EP study, coronary angio) 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 is already implanted with a 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 pregnant

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In office Outside walls of hospital<br>Reveal LINQ insertions will be performed in office setting. The in office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not an ambulatory surgery center. | Other: office setting<br>* An office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not including ambulatory surgical centers<br>|
| Other: Traditional Hospital Setting<br>Reveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory. | Other: hosptial setting<br>* A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Untoward Event Rate Associated With LINQ™ Insertions Performed | Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable. Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system. | 3 Months post insertion |