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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01965899
Registration number
NCT01965899
Ethics application status
Date submitted
16/10/2013
Date registered
18/10/2013
Date last updated
23/09/2016
Titles & IDs
Public title
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
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Scientific title
Reveal LINQ Usability Study
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Secondary ID [1]
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Reveal LINQ Usability Study
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Syncope
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Recurrent Symptomatic Atrial Fibrillation
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Insertable Cardiac Monitor Implant
Experimental: Insertable Cardiac Monitor Implant -
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Success of Wireless Transmissions
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Assessment method [1]
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To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
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Timepoint [1]
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30 days
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Primary outcome [2]
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R-wave Amplitude
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Assessment method [2]
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To characterize the signal quality of the R-wave amplitude at implant and one month.
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Timepoint [2]
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30 days
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Primary outcome [3]
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R-wave Amplitudes Greater Than or Equal to 200 µV
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Assessment method [3]
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The proportion of R-wave amplitudes that are greater than or equal to 200 µV will be estimated at implant and one month.
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Timepoint [3]
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30 days
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Secondary outcome [1]
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Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
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Assessment method [1]
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To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.
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Timepoint [1]
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4 months
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Secondary outcome [2]
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Safety Endpoint
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Assessment method [2]
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To characterize the system-related and procedure-related adverse events.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
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Assessment method [3]
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To compare the Reveal LINQ atrial fibrillation detection accuracy with atrial fibrillation detection from Holter monitoring. The true positive rate (sensitivity), specificity, positive predictive value and negative predictive value will be estimated using Holter recordings as the gold standard. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. The positive and negative predictive values are the proportion of positive and negative detected patients that are true positive and true negative, respectively. Accuracy measures the proportion of all patients that are correctly identified as negative or positive.
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Timepoint [3]
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48 hours
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Secondary outcome [4]
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Survey of the Implanting Physicians
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Assessment method [4]
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To understand the implanting physicians' experience with the implant of the Reveal LINQ, and the accompanying implanter tools. Responses to survey questions will be characterized. Below we summarize the responses to survey question "Overall, how would you rate the ease of entire implant procedure?".
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Timepoint [4]
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Day of implant
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Secondary outcome [5]
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Survey of the Patient Experience Over Time
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Assessment method [5]
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To understand the study subjects' experience with the Reveal LINQ, the patient assistant and the patient home monitor. Patient responses to survey questions will be characterized. Below we will summarize the responses to question "Based on your experience to date, please rate your satisfaction with the Reveal LINQ device" over 1 month, 6 month, and 12 month follow-up visit.
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Timepoint [5]
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12 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
99
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2015
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Sample size
Target
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Accrual to date
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Final
151
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Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
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Recruitment hospital [1]
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The Prince Charles Hospital - Brisbane
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Royal Melbourne Hospital - Melbourne
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Recruitment postcode(s) [1]
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4032 - Brisbane
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3050 - Melbourne
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Linz
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Belgium
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State/province [2]
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Leuven
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Belgium
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State/province [3]
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Yvoir
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Country [4]
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Netherlands
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State/province [4]
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Eindhoven
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Country [5]
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Netherlands
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State/province [5]
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Maastricht
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Netherlands
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State/province [6]
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Nieuwegein
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Country [7]
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Netherlands
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State/province [7]
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Utrecht
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Country [8]
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Netherlands
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State/province [8]
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Zwolle
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Russian Federation
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State/province [9]
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Novosibirsk
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Country [10]
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Slovakia
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State/province [10]
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Bratislava
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Country [11]
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United Kingdom
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State/province [11]
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Eastbourne
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Country [12]
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United Kingdom
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State/province [12]
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Middlesbrough
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Cardiac Rhythm and Heart Failure
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT01965899
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
Name
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Helmut Pürerfellner, MD
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Address
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Allgemein öffentliches Krankenhaus der Elisabethinen Linz
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01965899
Download to PDF