An interventional study of Out of cathlab insertion in Arrhythmia, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-02-11.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Not applicable, Interventional, and Health services research
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".
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".
885 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 191 is above the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Out of cathlab insertion
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).
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
| Milestone | Out of CathLab Setting |
|---|---|
| Started | 192 |
| Reveal linq implanted | 191 |
| Completed | 174 |
| Not completed | 18 |
| Withdrew: Lost to follow-up | 10 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: No reveal linq insertion attempt | 1 |
| Withdrew: Reveal linq explant | 1 |
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)
| Participants | Out of CathLab Setting |
|---|---|
| Number of Participants With Untoward Events | 0 |
Collected over All adverse events that were Reveal LINQ related, Reveal LINQ procedure related including any infections potentially resulting from the LINQ device or procedure as well as all serious events regardless of their relationship to the LINQ device or procedure were collected.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Out of CathLab Setting | 0/191 (0%) | 3/191 (1.6%) | 7/191 (3.7%) |
| Event | Out of CathLab Setting |
|---|---|
| Supraventricular tachycardiaCardiac disorders | 1/191 |
| cerebrovascular accidentNervous system disorders | 1/191 |
| syncopeNervous system disorders | 1/191 |
| Event | Out of CathLab Setting |
|---|---|
| Incision site haemorrhageInjury, poisoning and procedural complications | 2/191 |
| Supraventricular tachycardiaCardiac disorders | 1/191 |
| Implant site painGeneral disorders | 1/191 |
| cerebrovascular accidentNervous system disorders | 1/191 |
| PresyncopeNervous system disorders | 1/191 |
| SyncopeNervous system disorders | 1/191 |
Participants with Reveal LINQ Insertion Attempt
| Age, Continuous(years) | Out of CathLab Setting |
|---|---|
| Mean | 63.8 ± 26.9 |
| Sex: Female, Male(Participants) | Out of CathLab Setting |
|---|---|
| Female | 87 |
| Male | 104 |
| Race and Ethnicity Not Collected(Participants) | Out of CathLab Setting |
|---|
| Region of Enrollment(Participants) | Out of CathLab Setting |
|---|---|
| Australia | 34 |
| Canada | 28 |
| Germany | 28 |
| Italy | 15 |
| Netherlands | 32 |
| Spain | 35 |
| Sweden | 1 |
| United Kingdom | 15 |
| Body Mass Index (kg/m^2)(kg/m^2) | Out of CathLab Setting |
|---|---|
| Mean | 27.9 ± 4.8 |
| Cardiomyopathy(Participants) | Out of CathLab Setting |
|---|---|
| Count of participants | 10 |
| Congestive Heart Failure(Participants) | Out of CathLab Setting |
|---|---|
| Count of participants | 2 |
| Hypertension(Participants) | Out of CathLab Setting |
|---|---|
| Count of participants | 87 |
4 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure