Arrhythmia
Conditions
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.
Interventions
OTHEROut 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).
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Untoward Events | 3 months | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Out of CathLab Setting The insertion of the Reveal LINQ device will be performed in the out-of-cathlab setting.
Insertion of the Reveal LINQ device in the out of cathlab setting: Insertion of the Reveal LINQ device in the out-of-cathlab setting (out of the operating room, cardiac catheterization or electrophysiology laboratory). | 191 |
| Total | 191 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
| Overall Study | No Reveal LINQ Insertion Attempt | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Reveal LINQ explant | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Out of CathLab Setting | — |
|---|---|---|
| Age, Continuous | 63.8 years STANDARD_DEVIATION 26.9 | — |
| Body Mass Index (kg/m^2) | 27.9 kg/m^2 STANDARD_DEVIATION 4.8 | — |
| Cardiomyopathy | 10 Participants | — |
| Congestive Heart Failure | 2 Participants | — |
| Diabetes | 26 Participants | — |
| Hypertension | 87 Participants | — |
| Myocardial infarction | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 34 Participants | — |
| Region of Enrollment Canada | 28 Participants | — |
| Region of Enrollment Germany | 28 Participants | — |
| Region of Enrollment Italy | 15 Participants | — |
| Region of Enrollment Netherlands | 32 Participants | — |
| Region of Enrollment Spain | 35 Participants | — |
| Region of Enrollment Sweden | 1 Participants | — |
| Region of Enrollment United Kingdom | 15 Participants | — |
| Renal dysfunction | 8 Participants | — |
| Sex: Female, Male Female | 87 Participants | — |
| Sex: Female, Male Male | 104 Participants | — |
| Unexplained syncope | 83 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 191 |
| other Total, other adverse events | 7 / 191 |
| serious Total, serious adverse events | 3 / 191 |
Outcome results
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)
Time frame: 3 months
Population: Subjects exiting prematurely (prior to 3-month visit) without an untoward event were excluded from the primary analysis. There were 15 subjects exited prior to the 3-month visit all due to premature exit without having an untoward event
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Out of CathLab Setting | Number of Participants With Untoward Events | 0 Participants |
Comparison: There was no formal statistical hypothesis test associated with the primary outcome measure. Rather the goal of the primary study objective was to estimate the rate of untoward events associated with Reveal LINQ insertions performed in the out-of-cathlab setting through 3-months within a desired level of precision.95% CI: [0, 2.1]