Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

NCT ID: NCT01965899

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Syncope; Recurrent Symptomatic Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Insertable Cardiac Monitor Implant

Group Type: EXPERIMENTAL

Insertable Cardiac Monitor Implant

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Helmut Pürerfellner, MD

Role: PRINCIPAL_INVESTIGATOR

Allgemein öffentliches Krankenhaus der Elisabethinen Linz

Lukas Dekker, MD

Role: PRINCIPAL_INVESTIGATOR

Catharina Ziekenhuis

Locations

The Prince Charles Hospital

Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Allgemein öffentliches Krankenhaus der Elisabethinen Linz

Linz, , Austria

Allgemeines Krankenhaus der Stadt Linz

Linz, , Austria

UZ Leuven - Campus Gasthuisberg

Leuven, , Belgium

CHU UCL Mont-Godinne - Dinant

Yvoir, , Belgium

Catharina Ziekenhuis

Eindhoven, , Netherlands

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, , Netherlands

Diakonessenhuis Locatie Utrecht

Utrecht, , Netherlands

Isala Klinieken - Locatie Weezenlanden

Zwolle, , Netherlands

Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies

Novosibirsk, , Russia

Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)

Bratislava, , Slovakia

Eastbourne District General Hospital

Eastbourne, , United Kingdom

James Cook University Hospital

Middlesbrough, , United Kingdom

Countries

Australia; Austria; Belgium; Netherlands; Russia; Slovakia; United Kingdom

References

Saiz-Vivo J, Abdollahpur M, Mainardi LT, Corino VDA, De Melis M, Hatala R, Sandberg F. Heart rate characteristic based modelling of atrial fibrillatory rate using implanted cardiac monitor data. Physiol Meas. 2023 Mar 10;44(3). doi: 10.1088/1361-6579/acbc08.

Reference Type: DERIVED

PMID: 36787645 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25728756 (View on PubMed)

Other Identifiers

Reveal LINQ Usability Study

Identifier Type: -

Identifier Source: org_study_id