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

Arrhythmia Clinical Trial

— RIO2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412488
• Other study ID #: RIO2 International
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 20, 2016

Study information

• Verified date: September 2018
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: October 20, 2016
• Est. primary completion date: September 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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