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

NCT ID: NCT02395536

Last Updated: 2017-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-30
• Study Completion Date: 2016-05-31

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.

Conditions

Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

office setting

Intervention Type: OTHER

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

Traditional Hospital Setting

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

Group Type: OTHER

hosptial setting

Intervention Type: OTHER

A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.

Interventions

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

Intervention Type: OTHER

hosptial setting

A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Scripps Green Hospital

La Jolla, California, 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, 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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32207636 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27825975 (View on PubMed)

Other Identifiers

Version 1.0, 23 January 2015

Identifier Type: -

Identifier Source: org_study_id