Overview

This trial is active, not recruiting.

Condition arrhythmia
Treatment insertion of reveal linq device in office or traditional hospital setting
Phase phase 4
Sponsor Medtronic Cardiac Rhythm and Heart Failure
Start date March 2015
End date December 2016
Trial size 525 participants
Trial identifier NCT02395536, Version 1.0, 23 January 2015

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Reveal LINQ insertions will be performed in office setting.
insertion of reveal linq device in office or traditional hospital setting
The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in.
(Active Comparator)
Reveal LINQ insertions will be performed in IN-a traditional setting
insertion of reveal linq device in office or traditional hospital setting
The insterions will be performed in a Physician office setting or in Traditional Hospital Setting as per the arm the patient is randomized in.

Primary Outcomes

Measure
Untoward event rate associated with LINQ™ insertions performed
time frame: 3 Months post insertion

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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

Additional Information

Official title Reveal LINQ™ In-Office 2 (RIO 2) Study United States
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm and Heart Failure.