Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System

NCT01965899 | Completed Results

• 1 other identifier: Reveal LINQ Usability Study
• Study Type: interventional
• Target: 151
• Locations: 6 countries
• Sites: 14

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

Conditions

Syncope; Recurrent Symptomatic Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Success of Wireless Transmissions

  To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.

  30 days

• R-wave Amplitude

  To characterize the signal quality of the R-wave amplitude at implant and one month.

  30 days

• R-wave Amplitudes Greater Than or Equal to 200 μV

  The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.

  30 days

Secondary Outcomes (5)

• Accuracy of Reveal LINQ Device Detected Atrial Fibrillation

  4 months

• Safety Endpoint

  12 months

• Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor

  48 hours

• Survey of the Implanting Physicians

  Day of implant

• Survey of the Patient Experience Over Time

  12 months

Study Arms (1)

Insertable Cardiac Monitor Implant

EXPERIMENTAL

Device: Insertable Cardiac Monitor Implant

Interventions

Insertable Cardiac Monitor Implant 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.

Insertable Cardiac Monitor Implant

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (16)

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Allgemein öffentliches Krankenhaus der Elisabethinen Linz

Linz, Austria

Location

Allgemeines Krankenhaus der Stadt Linz

Linz, Austria

Location

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

CHU UCL Mont-Godinne - Dinant

Yvoir, Belgium

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

St. Antonius Ziekenhuis - Locatie Nieuwegein

Nieuwegein, Netherlands

Location

Diakonessenhuis Locatie Utrecht

Utrecht, Netherlands

Location

Isala Klinieken - Locatie Weezenlanden

Zwolle, Netherlands

Location

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

Novosibirsk, Russia

Location

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

Bratislava, Slovakia

Location

Eastbourne District General Hospital

Eastbourne, United Kingdom

Location

James Cook University Hospital

Middlesbrough, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 36787645 DERIVED

• 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.

  PMID: 25728756 DERIVED

MeSH Terms

Conditions

Syncope

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: CRHF Clinical Research
• Organization: Medtronic, plc

MedtronicCRMtrials@medtronic.com

800-328-2518

Study Officials

• Helmut Pürerfellner, MD

  Allgemein öffentliches Krankenhaus der Elisabethinen Linz

  PRINCIPAL INVESTIGATOR

• Lukas Dekker, MD

  Catharina Ziekenhuis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 18, 2013
• Study Start: September 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 23, 2016
• Results First Posted: September 23, 2016

Record last verified: 2016-06

Locations

SL (1); RU (1); GB (2); AU (3); BE (2); NL (5)