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

Medtronic

Status: Completed

Conditions: Arrhythmia

Treatments: Other: hosptial setting; Other: office setting

Study type: Interventional

Funder types: Industry

Identifiers

NCT02395536

Version 1.0, 23 January 2015

Details and patient eligibility

About

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).

Full 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.

Enrollment: 525 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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525 participants in 2 patient groups

In office Outside walls of hospital

Experimental group

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.

Treatment:

Other: office setting

Traditional Hospital Setting

Other group

Description:

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

Treatment:

Other: hosptial setting