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

Completed · Not applicable

Conditions studied: Arrhythmia

In brief

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).

Key facts

Study ID

NCT02395536

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

525

Starts

2015-03-30

Expected to finish

2016-05-31

Last updated by the study team

2017-10-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Green Hospital — La Jolla, California, United States
• Saint Joseph Heritage Healthcare — Mission Viejo, California, United States
• Regional Cardiology Associates (Sacramento CA) — Sacramento, California, United States
• Colorado Heart and Vascular, PC — Lakewood, Colorado, United States
• Cardiac Arrhythmia Service — Boca Raton, Florida, United States
• Clearwater Cardiovascular Consultants - Clearwater Office — Clearwater, Florida, United States
• Jim Moran Heart & Vascular-Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Tallahassee Research Institute Inc — Tallahassee, Florida, United States
• Georgia Arrhythmia Consultants — Macon, Georgia, United States
• Saint Elizabeth Healthcare — Edgewood, Kentucky, United States
• Delmarva Heart Research Foundation Inc — Salisbury, Maryland, United States
• Sparrow Clinical Research Institute — Lansing, Michigan, United States
• Cardiology Associates of North Mississippi — Tupelo, Mississippi, United States
• Mid America Heart Institute (MAHI) — Kansas City, Missouri, United States
• Lester E Cox Medical Center — Springfield, Missouri, United States
• Morristown Memorial Hospital — Newark, New Jersey, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Northwell Health — Great Neck, New York, United States
• The Mount Sinai Medical Center (New York NY) — New York, New York, United States
• Cone Health Medical Group HeartCare at Church Street — Greensboro, North Carolina, United States
• Raleigh Cardiology Associates — Raleigh, North Carolina, United States
• Oklahoma Heart Institute — Tulsa, Oklahoma, United States
• Diagnostic Cardiology Group — Chattanooga, Tennessee, United States
• Amarillo Heart Group — Amarillo, Texas, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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