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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Reveal LINQ Usability Study
Secondary ID [1] 0 0
Reveal LINQ Usability Study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Syncope 0 0
Recurrent Symptomatic Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Success of Wireless Transmissions
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
R-wave Amplitude
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
R-wave Amplitudes Greater Than or Equal to 200 µV
Timepoint [3] 0 0
30 days
Secondary outcome [1] 0 0
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
Timepoint [1] 0 0
4 months
Secondary outcome [2] 0 0
Safety Endpoint
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
Timepoint [3] 0 0
48 hours
Secondary outcome [4] 0 0
Survey of the Implanting Physicians
Timepoint [4] 0 0
Day of implant
Secondary outcome [5] 0 0
Survey of the Patient Experience Over Time
Timepoint [5] 0 0
12 months

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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4032 - Brisbane
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Belgium
State/province [3] 0 0
Yvoir
Country [4] 0 0
Netherlands
State/province [4] 0 0
Eindhoven
Country [5] 0 0
Netherlands
State/province [5] 0 0
Maastricht
Country [6] 0 0
Netherlands
State/province [6] 0 0
Nieuwegein
Country [7] 0 0
Netherlands
State/province [7] 0 0
Utrecht
Country [8] 0 0
Netherlands
State/province [8] 0 0
Zwolle
Country [9] 0 0
Russian Federation
State/province [9] 0 0
Novosibirsk
Country [10] 0 0
Slovakia
State/province [10] 0 0
Bratislava
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Eastbourne
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/ct2/show/NCT01965899
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Helmut Pürerfellner, MD
Address 0 0
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries