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

Not Applicable

Completed

Conditions: Arrhythmia

Interventions: Other: office setting
Other: hosptial setting

Registration Number: NCT02395536

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 525

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In office Outside walls of hospital	office setting	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.
Traditional Hospital Setting	hosptial setting	Reveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory.

Primary Outcome Measures

Name	Time	Method
Untoward Event Rate Associated With LINQ™ Insertions Performed	3 Months post insertion	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (27): Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Cardiology Associates of North Mississippi
🇺🇸
Tupelo, Mississippi, United States
Jim Moran Heart & Vascular-Holy Cross Hospital
🇺🇸
Fort Lauderdale, Florida, United States
Georgia Arrhythmia Consultants
🇺🇸
Macon, Georgia, United States
Sparrow Clinical Research Institute
🇺🇸
Lansing, Michigan, United States
Northwell Health
🇺🇸
Great Neck, New York, United States
Lester E Cox Medical Center
🇺🇸
Springfield, Missouri, United States
Scripps Green Hospital
🇺🇸
La Jolla, California, United States
Saint Joseph Heritage Healthcare
🇺🇸
Mission Viejo, California, United States
Saint Elizabeth Healthcare
🇺🇸
Edgewood, Kentucky, United States
Tallahassee Research Institute Inc
🇺🇸
Tallahassee, Florida, United States
Colorado Heart and Vascular, PC
🇺🇸
Lakewood, Colorado, United States
Oklahoma Heart Institute
🇺🇸
Tulsa, Oklahoma, United States
Morristown Memorial Hospital
🇺🇸
Newark, New Jersey, United States
Cone Health Medical Group HeartCare at Church Street
🇺🇸
Greensboro, North Carolina, United States
Raleigh Cardiology Associates
🇺🇸
Raleigh, North Carolina, United States
Amarillo Heart Group
🇺🇸
Amarillo, Texas, United States
The Mount Sinai Medical Center (New York NY)
🇺🇸
New York, New York, United States
Baylor Research Institute (Dallas TX)
🇺🇸
Dallas, Texas, United States
Lourdes Cardiology Services
🇺🇸
Voorhees, New Jersey, United States
Clearwater Cardiovascular Consultants - Clearwater Office
🇺🇸
Clearwater, Florida, United States
Cardiac Arrhythmia Service
🇺🇸
Boca Raton, Florida, United States
Diagnostic Cardiology Group
🇺🇸
Chattanooga, Tennessee, United States
Mid America Heart Institute (MAHI)
🇺🇸
Kansas City, Missouri, United States
Regional Cardiology Associates (Sacramento CA)
🇺🇸
Sacramento, California, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
Delmarva Heart Research Foundation Inc
🇺🇸
Salisbury, Maryland, United States