Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
RIO 2
Reveal LINQ™ In-Office 2 (RIO 2) Study United States
1 other identifier
interventional
525
1 country
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 23, 2015
CompletedStudy Start
First participant enrolled
March 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2016
CompletedResults Posted
Study results publicly available
October 4, 2017
CompletedOctober 4, 2017
May 1, 2017
1.2 years
March 17, 2015
May 9, 2017
May 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
In office Outside walls of hospital
EXPERIMENTALReveal 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
OTHERReveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory.
Interventions
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
A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Scripps Green Hospital
La Jolla, California, 92037, 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, 48912, 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
Baylor Research Institute (Dallas TX)
Dallas, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Related Publications (2)
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.
PMID: 32207636DERIVEDRogers 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.
PMID: 27825975DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
It was not possible to blind either the subject or implanting physician. The study exit rate after randomization but prior to REVEAL LINQ procedure was relatively high, but not unexpected given randomization needed to occur prior to the procedure.
Results Point of Contact
- Title
- Lindsay Werder, Senior Clinical Research Specialist
- Organization
- Medtronic, PLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The site of the Reveal LINQ insertion was randomized. Therefore it was not possible to blind the subject or the investigator.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2015
First Posted
March 23, 2015
Study Start
March 30, 2015
Primary Completion
May 31, 2016
Study Completion
May 31, 2016
Last Updated
October 4, 2017
Results First Posted
October 4, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share