SyncopeNCT01965899
Usability Study to Assess the Reveal LINQ Insertable Cardiac Monitor System
A study testing Insertable Cardiac Monitor Implant in people with Syncope and Recurrent Symptomatic Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 7 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Syncope, Recurrent Symptomatic Atrial Fibrillation
- What is being tested?
- Insertable Cardiac Monitor Implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 16 sitesin 7 countries
- Study dates
- Sep 2013to Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Netherlands5 sites
Catharina Ziekenhuis
Eindhoven
Academisch Ziekenhuis Maastricht
Maastricht
St. Antonius Ziekenhuis - Locatie Nieuwegein
Nieuwegein
Diakonessenhuis Locatie Utrecht
Utrecht
Isala Klinieken - Locatie Weezenlanden
Zwolle
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Prince Charles Hospital
Brisbane, Queensland, 4032
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Austria2 sites
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Linz
Allgemeines Krankenhaus der Stadt Linz
Linz
Belgium2 sites
UZ Leuven - Campus Gasthuisberg
Leuven
CHU UCL Mont-Godinne - Dinant
Yvoir
United Kingdom2 sites
Eastbourne District General Hospital
Eastbourne
James Cook University Hospital
Middlesbrough
Russia1 site
Scientific Research Institute of Circulation's Pathology Agency on High Medical Technologies
Novosibirsk
Slovakia1 site
Narodny ustav srdcovych a cievnych chorob, a.s. (NUSCH)
Bratislava
About this study
Official title: Reveal LINQ Usability Study
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
Read the 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
- Being tested
- Insertable Cardiac Monitor Implant
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertable Cardiac Monitor ImplantDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Insertable Cardiac Monitor Implant | Experimental | Not described Receives: Device: Insertable Cardiac Monitor Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Wireless Transmissions
To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
Measured: 30 days
R-wave Amplitude
To characterize the signal quality of the R-wave amplitude at implant and one month.
Measured: 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.
Measured: 30 days
Secondary outcomes (5)
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
To assess atrial fibrillation detection by the Reveal LINQ insertable cardiac monitor (ICM). True and false positives will be reported.
Measured: 4 months
Safety Endpoint
To characterize the system-related and procedure-related adverse events.
Measured: 12 months
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
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.
Measured: 48 hours
Survey of the Implanting Physicians
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?".
Measured: Day of implant
Survey of the Patient Experience Over Time
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Pürerfellner, MD, Principal investigator, Allgemein öffentliches Krankenhaus der Elisabethinen LinzLukas Dekker, MD, Principal investigator, Catharina Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01965899
- Sponsor's protocol ID
- Reveal LINQ Usability Study
- Status last verified
- Jun 2016
- First submitted
- 16 Oct 2013
- Last updated
- 23 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 36787645Purerfellner 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.
PubMed 25728756
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reveal LINQ Usability Study
- ClinicalTrials.gov ID
- NCT01965899
- Acronym / sponsor ID
- Reveal LINQ Usability Study
- Conditions
- Syncope, Recurrent Symptomatic Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Oct 2013 (estimated)
- Results
- Posted 23 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insertable Cardiac Monitor Implant | Experimental | Device: Insertable Cardiac Monitor Implant |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertable Cardiac Monitor ImplantThe 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. | Device | Insertable Cardiac Monitor Implant |
Primary outcome
Success of Wireless Transmissions
Time frame: 30 days
To assess the percentage of successful automatic wireless transmissions from the system within the first 30 days of implant.
R-wave Amplitude
Time frame: 30 days
To characterize the signal quality of the R-wave amplitude at implant and one month.
R-wave Amplitudes Greater Than or Equal to 200 μV
Time frame: 30 days
The proportion of R-wave amplitudes that are greater than or equal to 200 μV will be estimated at implant and one month.
5 secondary outcomes
Accuracy of Reveal LINQ Device Detected Atrial Fibrillation
Time frame: 4 months
Safety Endpoint
Time frame: 12 months
Accuracy of Device Detected Atrial Fibrillation Compared to Holter Monitor
Time frame: 48 hours
Survey of the Implanting Physicians
Time frame: Day of implant
Survey of the Patient Experience Over Time
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36787645Saiz-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.
- Derived from this study: PubMed 25728756Purerfellner 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Pürerfellner, MD principal investigator
Allgemein öffentliches Krankenhaus der Elisabethinen Linz
Lukas Dekker, MD principal investigator
Catharina Ziekenhuis
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insertable Cardiac Monitor Implant in people with Syncope and Recurrent Symptomatic Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Netherlands, Australia, Austria, Belgium, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of Wireless Transmissions (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01965899, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2016.