Clinical trial NCT01965899: Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
Official title: Reveal LINQ Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Recurrent Symptomatic Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subject is willing to sign and date the consent form.
* Subject is indicated for a Reveal device within the existing market approved indications
* Phase I (initial 30 subjects): Any indication for a Reveal LINQ Device
* Phase II (after the initial 30 subjects): Subject has atrial fibrillation and is indicated for and identified as an AF pre-ablation candidate\*

  \*Note: Atrial fibrillation must be documented in the subject's medical history.
* Subject has a life expectancy of 18 months or more.
* Subject is willing and able to set up and utilize MyCareLink® home monitor and be remotely monitored (i.e., Medtronic CareLink® Network)
* Subjects who are female of childbearing potential (last menses less than 1 year prior to enrolment) must:
* have a negative pregnancy test at enrollment.
* not be breastfeeding.
* either be surgically sterile, postmenopausal (cessation of menses for at least 1 year), or agree to use a medically accepted, highly effective method of contraception during the entire duration of the study.

Exclusion Criteria:

* Subject has an active implanted cardiac medical device (e.g., IPG, ICD, CRT, etc).
* Subject is unwilling or unable to comply with the study procedures
* Subject is legally incapacitated and unable to provide written informed consent.
* Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse, emotional/psychological diagnosis)
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from Medtronic study manager.
* Local law prohibits participation (e.g., minor status as specified by local law)

Primary outcomes:
measure: Success of Wireless Transmissions
timeFrame: 30 days
measure: R-wave Amplitude
timeFrame: 30 days
measure: R-wave Amplitudes Greater Than or Equal to 200 μV
timeFrame: 30 days
Secondary outcomes:
measure: Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
timeFrame: 4 months
measure: Safety Endpoint
timeFrame: 12 months
measure: Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
timeFrame: 48 hours
measure: Survey of the Implanting Physicians
timeFrame: Day of implant
measure: Survey of the Patient Experience Over Time
timeFrame: 12 months
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Linz
country: Austria
facility: Allgemein öffentliches Krankenhaus der Elisabethinen Linz
city: Linz
country: Austria
facility: Allgemeines Krankenhaus der Stadt Linz
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Yvoir
country: Belgium
facility: CHU UCL Mont-Godinne - Dinant
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis - Locatie Nieuwegein
city: Utrecht
country: Netherlands
facility: Diakonessenhuis Locatie Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken - Locatie Weezenlanden
city: Novosibirsk
country: Russian Federation
facility: Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
city: Eastbourne
country: United Kingdom
facility: Eastbourne District General Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
Study officials:
affiliation: Allgemein öffentliches Krankenhaus der Elisabethinen Linz
name: Helmut Pürerfellner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis
name: Lukas Dekker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Purerfellner H, Sanders P, Pokushalov E, Di Bacco M, Bergemann T, Dekker LR; Reveal LINQ Usability Study Investigators. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm. 2015 Jun;12(6):1113-9. doi: 10.1016/j.hrthm.2015.02.030. Epub 2015 Feb 26.