NCT02395536: RIO 2

Medtronic Reveal LINQ™ In-Office 2 (RIO 2) Study United States

Completed NA Results posted Last updated 4 October 2017

What this trial tests

NA trial testing office setting in Arrhythmia in 525 participants. Completed in 31 May 2016.

Timeline

30 March 2015

Primary endpoint
31 May 2016

31 May 2016

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	525
Start date	30 March 2015
Primary completion	31 May 2016
Estimated completion	31 May 2016
Sites	27 locations across United States

Drugs / interventions tested

• office setting
• hosptial setting

Conditions studied

• Arrhythmia — all drugs for Arrhythmia →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

Adults 18 to 99, any sex, with Arrhythmia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Untoward Event Rate Associated With LINQ™ Insertions Performed Primary · 3 Months post insertion

Demonstrate that the untoward event rate associated with Reveal LINQ™ insertions performed in-office or in the traditional hospital setting (operating room, cardiac catheterization or EP laboratory) are comparable. Untoward events are a composite of unsuccessful Reveal LINQ™ or complications related to the Reveal LINQ™ insertion procedure or system.

Group	Value	95% CI
In Office Outside Walls of Hospital	2
Traditional Hospital Setting	2

Adverse events — posted to ClinicalTrials.gov

Time frame: All adeverse events potentially related to the REVEAL LINQ insertion procedure or system were collected from consent through the end of study participation (3-months post-procedure). Additionally all deaths were collected.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

In Office Outside Walls of Hospital

Serious: 3/251 (1%)

Deaths: 2/251

Traditional Hospital Setting

Serious: 0/231 (0%)

Deaths: 0/231

Serious adverse events (3 terms)

Reaction	System	In Office Outside Walls of…	Traditional Hospital Setting
Atrioventricular block complete	Cardiac disorders	—	—
Incision Site Haemorrhage	Injury, poisoning and procedural complications	—	—
Cerebral Haemorrhage	Nervous system disorders	—	—

Other adverse events (13 terms — click to expand)

Reaction	System	In Office Outside Walls of…	Traditional Hospital Setting
Incision site haemorrhage	Injury, poisoning and procedural complications	—	—
Procedural dizziness	Injury, poisoning and procedural complications	—	—
Atrioventricular block complete	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Device dislocation	General disorders	—	—
Device extrusion	General disorders	—	—
Implant site bruising	General disorders	—	—
Implant site rash	General disorders	—	—
Incision site complication	Injury, poisoning and procedural complications	—	—
Wound dehiscence	Injury, poisoning and procedural complications	—	—
Cerebral haemorrhage	Nervous system disorders	—	—
Presyncope	Nervous system disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Atrioventricular block complete, Incision Site Haemorrhage, Cerebral Haemorrhage.

Data from ClinicalTrials.gov NCT02395536 adverse events section.

Sponsor's own description

The primary purpose of the RIO 2 study is to demonstrate that when the Reveal LINQ™ insertable cardiac monitoring (ICM) system that records subcutaneous ECG insertion procedure performed in the in-office setting is as safe as LINQ™ insertions performed in the traditional hospital setting (operating room, cardiac catheterization or electrophysiology (EP) laboratory).

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. In-office insertion of a miniaturized insertable cardiac monitor: Results from the Reveal LINQ In-Office 2 randomized study.
   Rogers JD, Sanders P, Piorkowski C, Sohail MR, et al · · 2017 · cited 33× · PMID 27825975 · DOI 10.1016/j.hrthm.2016.11.001
2. Insertion of miniaturized cardiac monitors outside the catheter operating room: experience and practical advice.
   Steffel J, Wright DJ, Schäfer H, Rashid-Fadel T, et al · · 2017 · cited 12× · PMID 28340242 · DOI 10.1093/europace/euw304
3. Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study.
   Rogers JD, Piorkowski C, Sohail MR, Anand R, et al · · 2020 · cited 1× · PMID 32207636 · DOI 10.1080/13696998.2020.1746548