NCT01965899

Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

Reveal LINQ Usability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Reveal LINQ Usability Study is to assess the functionality of the Reveal LINQ insertable cardiac monitor and accompanying system in patients indicated for an insertable cardiac monitor

Detailed description

The Reveal LINQ Usability Study is a prospective, non-blinded, non-randomized, multi-center clinical trial. Subjects will transmit device data via manual interrogation on a weekly basis during the first month and will be evaluated in the office at 1-month post-implant, in addition to an automatic nightly wireless data transmission using the MyCareLink® home monitor. All subjects will be requested to wear an external Holter for 48 hours at approximately 4 weeks post-insertion. Follow-up visits will continue at 6 and 12 months post-implant, with monthly manual interrogations. Subjects will be exited at their 12 month follow-up visit. The overall study will be conducted in 2 phases which differ primarily on inclusion criteria: Phase I subjects (initial 30 subjects) will have any indication for an ICM, Phase II subjects (all subjects following the initial 30 subjects) will be atrial fibrillation (AF) pre-ablation patients. The study will assess functionality of the Reveal LINQ device by assessing sensing performance and data transmission.

Conditions

• Syncope
• Recurrent Symptomatic Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Insertable Cardiac Monitor Implant	The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-07-01
• Completion: 2015-09-01
• First posted: 2013-10-18
• Last updated: 2016-09-23
• Results posted: 2016-09-23

Locations

16 sites across 7 countries: Australia, Austria, Belgium, Netherlands, Russia, Slovakia, United Kingdom