Clinical trial NCT02412488: Reveal LINQ™ In-Office 2 (RIO2) Study International
Official title: Reveal LINQ™ In-Office 2 (RIO2) International Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2015-04-09
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

Detailed description: The traditional location of the LINQ™ insertion procedure is the catheterization laboratory, electrophysiology laboratory, or operating room. The purpose of the RIO 2 International study is to provide clinical and economic evidence to support moving the LINQ™ insertion procedure outside these traditional locations within the hospital, referred to as "out-of-cathlab".

Eligibility criteria: Inclusion Criteria:

* Patient is indicated for continuous arrhythmia monitoring with a Reveal LINQ™ Insertable Cardiac Monitor (ICM)
* Patient is at least 18 years of age or older if required by local regulations
* Patient is willing to undergo ICM insertion procedure outside of the cathlab, operating room, 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 elements of the clinical investigation plan including the required follow-up

Exclusion Criteria:

* Patient has unusual thoracic anatomy or scarring at the insertion site which may adversely affect the success of the insertion 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 intra-arterial access (e.g. AF/VT ablation, EP study, coronary angiography) 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 already has an inserted or implanted 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 legally incapable of giving consent
* Patient is pregnant\* \*Note: Possible pregnancy will be assessed by the physician asking the patient; a pregnancy test is not required

Primary outcomes:
measure: Number of Participants With Untoward Events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medtronic
name: RIO2 Clinical Study Specialist
role: STUDY_CHAIR
References:
citation: Sanders P, Piorkowski C, Kragten JA, Goode GK, Raj SR, Dinh T, Sohail MR, Anand R, Moya-Mitjans A, Franco N, Stromberg K, Rogers JD. Safety of in-hospital insertable cardiac monitor procedures performed outside the traditional settings: results from the Reveal LINQ in-office 2 international study. BMC Cardiovasc Disord. 2019 May 31;19(1):132. doi: 10.1186/s12872-019-1106-3.