Reveal LINQ™ In-Office 2 (RIO2) Study International

NCT02412488 | Completed Results

• 1 other identifier: RIO2 International
• Study Type: interventional
• Target: 191
• Locations: 0 countries
• Sites: N/A

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".

Conditions

Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Untoward Events

  An untoward event is a composite endpoint defined as a LINQTM or LINQTM insertion procedure related complication OR an unsuccessful LINQTM insertion procedure, where a LINQTM or LINQTM insertion procedure related complication is defined as an adverse event related to the LINQTM or a LINQTM insertion procedure resulting in: * Death * Termination of significant device function * Invasive intervention (e.g. includes LINQTM revision/explant for reasons other than diagnosis of underlying condition, intravenous drug administration)

  3 months

Study Arms (1)

Out of CathLab setting

EXPERIMENTAL

Out of cathlab insertion

Other: Out of cathlab insertion

Interventions

Out of cathlab insertion OTHER

Insertion of the Reveal LINQ device in the "out-of-cathlab" setting (out of the operating room, cardiac catheterization or electrophysiology laboratory).

Out of CathLab setting

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Related Publications (1)

• 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.

  PMID: 31151383 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a single arm study

Results Point of Contact

• Title: Lindsay Werder, Senior Clinical Research Specialist
• Organization: Medtronic, PLC

lindsay.k.werder@medtronic.com

7635268168

Study Officials

• RIO2 Clinical Study Specialist

  Medtronic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 9, 2015
• Study Start: February 1, 2015
• Primary Completion: September 22, 2016
• Study Completion: October 20, 2016
• Last Updated: February 11, 2019
• Results First Posted: February 11, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share