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

Arrhythmia Clinical Trial

— RIO 2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02395536
• Other study ID #: Version 1.0, 23 January 2015
• Status: Completed
• Phase: N/A
• First received: March 17, 2015
• Last updated: May 9, 2017
• Start date: March 30, 2015
• Est. completion date: May 31, 2016

Study information

• Verified date: May 2017
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: May 31, 2016
• Est. primary completion date: May 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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