N/A Completed N=521 Randomized Health Services Research

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

Arrhythmias

Source: ClinicalTrials.gov NCT02395536 ↗

Enrolled (actual)

521

Serious AEs

0.6%

Results posted

Oct 2017

Primary outcomePrimary: Untoward Event Rate Associated With LINQ™ Insertions Performed — 2; 2 Participants — p=<0.001

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Untoward Event Rate Associated With LINQ™ Insertions Performed	2; 2	<0.001 sig

Eligibility Criteria

Inclusion Criteria

Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor
Patient is 18 years of age or older
Patient is willing to undergo ICM insertion procedure outside of the cath lab, OR, EP lab setting with only local anesthetic
Patient is willing and able to provide consent and authorize the use and disclosure of health information
Patient is willing and able to comply with the protocol including the required follow-up

Exclusion Criteria

Patient has unusual thoracic anatomy or scarring at the implant site which may adversely affect the success of the implant procedure
Patient has reduced immune function or is otherwise at high risk for infection per physician discretion
Current therapy with immunosuppressive agents or chronic steroid use e.g. Prednisone greater than 20mg per day
Patient requires hemodialysis
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.
Patient has had major surgery (in the past 6 months)
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.
Prior history of surgical infection, prosthetic device infection, or endovascular infection, including endocarditis, in the past 12 months.
Patient has a central venous port, an atrio-venous fistula, or a prosthetic valve
Patient requires conscious or moderate sedation to receive LINQ™
Patient is already implanted with a loop recorder
Patient is implanted or indicated for implant with a pacemaker, ICD, CRT device
Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
Patient's life expectancy is less than 6 months
Patient is pregnant

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02395536). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.