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

Primary Purpose

Arrhythmia

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Out of cathlab insertion

About this trial

This is an interventional health services research trial for Arrhythmia

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Out of CathLab setting

Arm Description

Out of cathlab insertion

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT02412488

First Posted

April 6, 2015

Last Updated

September 12, 2018

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT02412488

Brief Title

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

Acronym

RIO2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

September 22, 2016 (Actual)

Study Completion Date

October 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Data Monitoring Committee

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arrhythmia

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

191 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Out of CathLab setting

Arm Type

Experimental

Arm Description

Out of cathlab insertion

Intervention Type

Other

Intervention Name(s)

Out of cathlab insertion

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants With Untoward Events

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

RIO2 Clinical Study Specialist

Organizational Affiliation

Medtronic

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31151383

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.

Results Reference

derived

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

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