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

Primary Purpose

Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
office setting
hosptial setting
Sponsored by
Medtronic Cardiac Rhythm and Heart Failure
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Arrhythmia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Green Hospital
  • Saint Joseph Heritage Healthcare
  • Regional Cardiology Associates (Sacramento CA)
  • Colorado Heart and Vascular, PC
  • Cardiac Arrhythmia Service
  • Clearwater Cardiovascular Consultants - Clearwater Office
  • Jim Moran Heart & Vascular-Holy Cross Hospital
  • Tallahassee Research Institute Inc
  • Georgia Arrhythmia Consultants
  • Saint Elizabeth Healthcare
  • Delmarva Heart Research Foundation Inc
  • Sparrow Clinical Research Institute
  • Cardiology Associates of North Mississippi
  • Mid America Heart Institute (MAHI)
  • Lester E Cox Medical Center
  • Morristown Memorial Hospital
  • Lourdes Cardiology Services
  • Northwell Health
  • The Mount Sinai Medical Center (New York NY)
  • Cone Health Medical Group HeartCare at Church Street
  • Raleigh Cardiology Associates
  • Oklahoma Heart Institute
  • Diagnostic Cardiology Group
  • Amarillo Heart Group
  • Texas Cardiac Arrhythmia Research Foundation
  • Baylor Research Institute (Dallas TX)
  • Sentara Norfolk General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

In office Outside walls of hospital

Traditional Hospital Setting

Arm Description

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.

Reveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 17, 2015
Last Updated
May 9, 2017
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
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1. Study Identification

Unique Protocol Identification Number
NCT02395536
Brief Title
Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
Acronym
RIO 2
Official Title
Reveal LINQ™ In-Office 2 (RIO 2) Study United States
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 30, 2015 (Actual)
Primary Completion Date
May 31, 2016 (Actual)
Study Completion Date
May 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The site of the Reveal LINQ insertion was randomized. Therefore it was not possible to blind the subject or the investigator.
Allocation
Randomized
Enrollment
525 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In office Outside walls of hospital
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional Hospital Setting
Arm Type
Other
Arm Description
Reveal LINQ insertions will be performed in a traditional setting. The traditional hospital setting includes an operating room or electrophysiology laboratory.
Intervention Type
Other
Intervention Name(s)
office setting
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
hosptial setting
Intervention Description
A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.
Primary Outcome Measure Information:
Title
Untoward Event Rate Associated With LINQ™ Insertions Performed
Description
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.
Time Frame
3 Months post insertion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Saint Joseph Heritage Healthcare
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Regional Cardiology Associates (Sacramento CA)
City
Sacramento
State/Province
California
Country
United States
Facility Name
Colorado Heart and Vascular, PC
City
Lakewood
State/Province
Colorado
Country
United States
Facility Name
Cardiac Arrhythmia Service
City
Boca Raton
State/Province
Florida
Country
United States
Facility Name
Clearwater Cardiovascular Consultants - Clearwater Office
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Jim Moran Heart & Vascular-Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
Tallahassee Research Institute Inc
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Georgia Arrhythmia Consultants
City
Macon
State/Province
Georgia
Country
United States
Facility Name
Saint Elizabeth Healthcare
City
Edgewood
State/Province
Kentucky
Country
United States
Facility Name
Delmarva Heart Research Foundation Inc
City
Salisbury
State/Province
Maryland
Country
United States
Facility Name
Sparrow Clinical Research Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Cardiology Associates of North Mississippi
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
Mid America Heart Institute (MAHI)
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Lester E Cox Medical Center
City
Springfield
State/Province
Missouri
Country
United States
Facility Name
Morristown Memorial Hospital
City
Newark
State/Province
New Jersey
Country
United States
Facility Name
Lourdes Cardiology Services
City
Voorhees
State/Province
New Jersey
Country
United States
Facility Name
Northwell Health
City
Great Neck
State/Province
New York
Country
United States
Facility Name
The Mount Sinai Medical Center (New York NY)
City
New York
State/Province
New York
Country
United States
Facility Name
Cone Health Medical Group HeartCare at Church Street
City
Greensboro
State/Province
North Carolina
Country
United States
Facility Name
Raleigh Cardiology Associates
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Diagnostic Cardiology Group
City
Chattanooga
State/Province
Tennessee
Country
United States
Facility Name
Amarillo Heart Group
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
Country
United States
Facility Name
Baylor Research Institute (Dallas TX)
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32207636
Citation
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.
Results Reference
derived
PubMed Identifier
27825975
Citation
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.
Results Reference
derived

Learn more about this trial

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

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