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

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

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).

Study Overview

• Status: Completed
• Conditions: Arrhythmia
• Intervention / Treatment: Other: office setting; Other: hosptial setting

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.

• Study Type: Interventional
• Enrollment (Actual): 525
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Green Hospital
    • Mission Viejo, California, United States
      • Saint Joseph Heritage Healthcare
    • Sacramento, California, United States
      • Regional Cardiology Associates (Sacramento CA)
  • Colorado
    • Lakewood, Colorado, United States
      • Colorado Heart and Vascular, PC
  • Florida
    • Boca Raton, Florida, United States
      • Cardiac Arrhythmia Service
    • Clearwater, Florida, United States
      • Clearwater Cardiovascular Consultants - Clearwater Office
    • Fort Lauderdale, Florida, United States
      • Jim Moran Heart & Vascular-Holy Cross Hospital
    • Tallahassee, Florida, United States
      • Tallahassee Research Institute Inc
  • Georgia
    • Macon, Georgia, United States
      • Georgia Arrhythmia Consultants
  • Kentucky
    • Edgewood, Kentucky, United States
      • Saint Elizabeth Healthcare
  • Maryland
    • Salisbury, Maryland, United States
      • Delmarva Heart Research Foundation Inc
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Sparrow Clinical Research Institute
  • Mississippi
    • Tupelo, Mississippi, United States
      • Cardiology Associates of North Mississippi
  • Missouri
    • Kansas City, Missouri, United States
      • Mid America Heart Institute (MAHI)
    • Springfield, Missouri, United States
      • Lester E Cox Medical Center
  • New Jersey
    • Newark, New Jersey, United States
      • Morristown Memorial Hospital
    • Voorhees, New Jersey, United States
      • Lourdes Cardiology Services
  • New York
    • Great Neck, New York, United States
      • Northwell Health
    • New York, New York, United States
      • The Mount Sinai Medical Center (New York NY)
  • North Carolina
    • Greensboro, North Carolina, United States
      • Cone Health Medical Group HeartCare at Church Street
    • Raleigh, North Carolina, United States
      • Raleigh Cardiology Associates
  • Oklahoma
    • Tulsa, Oklahoma, United States
      • Oklahoma Heart Institute
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Diagnostic Cardiology Group
  • Texas
    • Amarillo, Texas, United States
      • Amarillo Heart Group
    • Austin, Texas, United States
      • Texas Cardiac Arrhythmia Research Foundation
    • Dallas, Texas, United States
      • Baylor Research Institute (Dallas TX)
  • Virginia
    • Norfolk, Virginia, United States
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor
2. Patient is 18 years of age or older
3. Patient is willing to undergo ICM insertion procedure outside of the cath lab, OR, EP lab setting with only local anesthetic
4. Patient is willing and able to provide consent and authorize the use and disclosure of health information
5. Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria:

1. Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
2. Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
3. Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
4. Patient requires hemodialysis
5. 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.
6. Patient has had major surgery (in the past 6 months)
7. 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.
8. Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
9. Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
10. Patient requires conscious or moderate sedation to receive LINQ™
11. Patient is already implanted with a loop recorder
12. Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
13. Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
14. Patient's life expectancy is less than 6 months
15. Patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: In office Outside walls of hospital; 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; 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
OTHER: Traditional Hospital Setting; Reveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory.	Other: hosptial setting; A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Publications and helpful links

General Publications

• Rogers JD, Piorkowski C, Sohail MR, Anand R, Kowalski M, Rosemas S, Stromberg K, Sanders P. Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study. J Med Econ. 2020 Jul;23(7):706-713. doi: 10.1080/13696998.2020.1746548. Epub 2020 May 1.
• Rogers JD, Sanders P, Piorkowski C, Sohail MR, Anand R, Crossen K, Khairallah FS, Kaplon RE, Stromberg K, Kowal RC. In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study. Heart Rhythm. 2017 Feb;14(2):218-224. doi: 10.1016/j.hrthm.2016.11.001. Epub 2016 Nov 4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2015
• Primary Completion (ACTUAL): May 31, 2016
• Study Completion (ACTUAL): May 31, 2016

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 20, 2015
• First Posted (ESTIMATE): March 23, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: Version 1.0, 23 January 2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO