Reveal LINQ Usability Study
Research type
Research Study
Full title
Reveal LINQ Usability Study
IRAS ID
128077
Contact name
Nick Linker
Contact email
Sponsor organisation
Medtronic Inc
Research summary
The Reveal LINQ system comprises of a Reveal LINQ Insertable Cardiac Monitor (ICM) with an incision and pre-loaded in the insertion tool, My CareLink Monitor, Patient Assistant, CareLink Software, Medtronic Programmer with software.
Reveal LINQ ICM with functionality similar to the predecessor device, Reveal XT. It is a small implantable device (smaller than a USB stick) that continuously monitors heart rhythms and records them automatically. Significant pre-clinical testing via bench and animal models along with research feasibility activities have been performed to ensure product quality and optimize system performance. Pre-clinical testing represents aspects of the implant scenario and device functionality, but are not fully representative of the device’s operation in the human and dont allow for the verification of end-user acceptance.
The aim of the study is to assess the usability and functionality of the Reveal LINQ system in patients by assessing sensing performance and data transmission. The outcome of the study will provide further evidence to support the post-market launch of the Reveal LINQ device and it's supporting components. Reveal LINQ also has a built in algoithm to provide better detection and diagnosis of AF.
The study has 2 arms, however the UK will only be a part of Phase II, which looks to enroll 120 patients with known atrial fibrillation (AF) who are candidates for ablation.
Eligible patients will be informed about the study, consented in accordance with guidelines, enrolled and implanted with a Reveal LINQ device. The Reveal LINQ device will be implanted subcutaneously using the incision and insertion tool, in a minimally invasive procedure under local anesthesia. During the 12 month follow up patients will have a clinic visit at 1 month, 6 months and 12 months and will transmit data device data remotely on a weekly basis for the first month and monthly thereafter until study end.
REC name
North East - York Research Ethics Committee
REC reference
13/NE/0283
Date of REC Opinion
28 Oct 2013
REC opinion
Further Information Favourable Opinion