Clinical trial NCT02395536: Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States
Official title: Reveal LINQ™ In-Office 2 (RIO 2) Study United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2015-03-23
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Untoward Event Rate Associated With LINQ™ Insertions Performed
timeFrame: 3 Months post insertion
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Mission Viejo
country: United States
facility: Saint Joseph Heritage Healthcare
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates (Sacramento CA)
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular, PC
state: Colorado
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Service
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants - Clearwater Office
state: Florida
city: Fort Lauderdale
country: United States
facility: Jim Moran Heart & Vascular-Holy Cross Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute Inc
state: Florida
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Edgewood
country: United States
facility: Saint Elizabeth Healthcare
state: Kentucky
city: Salisbury
country: United States
facility: Delmarva Heart Research Foundation Inc
state: Maryland
city: Lansing
country: United States
facility: Sparrow Clinical Research Institute
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Kansas City
country: United States
facility: Mid America Heart Institute (MAHI)
state: Missouri
city: Springfield
country: United States
facility: Lester E Cox Medical Center
state: Missouri
city: Newark
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: The Mount Sinai Medical Center (New York NY)
state: New York
city: Greensboro
country: United States
facility: Cone Health Medical Group HeartCare at Church Street
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Cardiology Associates
state: North Carolina
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Chattanooga
country: United States
facility: Diagnostic Cardiology Group
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Heart Group
state: Texas
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Baylor Research Institute (Dallas TX)
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
References:
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.
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.