Cardiac ArrythmiasNCT03720639
Confirm Rx™ Versus Reveal LINQ™ - Which is More Reliable in Data Transmission? A Randomized Clinical Study
A study testing Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM in people with Cardiac Arrythmias and Syncope, run by Sparrow Clinical Research Institute at 2 sites in United States.
Trial summary
This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrythmias, Syncope, Atrial Fibrillation
- What is being tested?
- Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 May 2018to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 years of age or older
- Patient is willing and able to provide written informed consent
- Patient is willing and able to comply with the protocol, including follow-up visits and MyCareLink™ and Merlin™ transmissions (standard of care)
- Candidates for implantable cardiac monitor
Who cannot join
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a study manager
- Patient has existing IPG, ICD, CRT-D or CRT-P device
- Adequate sensing in one week post implant. If sensing not adequate, patient will be in the registry.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sparrow Clinical Research Institute
Lansing, Michigan, 48912
Munson Medical Center
Traverse City, Michigan, 49684
About this study
Official title: Confirm Rx™ Versus Reveal LINQ™ -Which is More Reliable in Data Transmission? A Randomized Clinical Study
This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder.
Read the detailed description
Implantable cardiac monitor (ICM) is an invaluable tool for diagnosing cardiac arrhythmia (1). Cryptogenic stroke, unexplained syncope and arrhythmia diagnosis are the most common indication for long term cardiac monitoring device. (2, 3). Reveal LINQTM (Medtronic, Inc.) is widely used for all of these purposes in the country. We have previously reported the use of Reveal XT in the use of atrial fibrillation (AF) surveillance in patient's post-AF ablation (2). We indicated that ICM is useful in long term monitoring of atrial arrhythmia in patients at risk of atrial fibrillation. Crystal AF (4) study also showed the importance of using ICM in detecting occult AF in patients with cryptogenic stroke in a timely manner so that appropriate treatment can be prescribed. The key to the success of ICM rest on how timely and reliable the ICM data can be transmitted to physician's office immediately after an arrhythmic events so the data can be analyzed and treatment rendered. Reveal LINQTM data transmission consists of two steps: 1. Data needs to be download into the MyCareLink™ monitor (scheduled daily at 2 am in the morning and monitor needs to be in the within 6 feet proximity of the patient) 2. MyCareLink™ monitor to be connected to the 3 G cellular network for the data transmission. (Fig 1). In cases of patient activated events, data transmission utilizes similar pathway.
We have reported significant delay in data transmission in the Reveal LINQTM occurs frequently and failure to connect among the Reveal LINQTM, MyCareLink™ monitor and the cellular network is the main reason for data transmission disruption and critical data could be concealed for an extended periods. To illustrate the importance of timely transmission of patient data, a Reveal LINQTM was implanted in a 54-year-old gentle man with past medical history of recurrent syncope. On 8/12/2017 the patient developed new onset dizziness and 6 seconds sinus pause was recorded by the device. However, a connection problem of MyCarelinkTM system made data unavailable until next scheduled office visit on 11/15/2017. The physician was notified on the same day and a pacemaker was implanted on the following day, almost 3 months after his significant arrhythmic events.
The newer generation of ICM such as Confirm Rx™ (Abbott, Inc) is connected directly to a patient's existing smartphone using the Bluetooth technology. By allowing patients to record and transmit symptoms with the mobile app, Confirm Rx™ ICM brings continuous remote monitoring to patients without the need for a home-based monitor (Fig 2). It is unclear which technologies offers faster and more reliable transmission of critical patient information to physician office so timely treatment can be provided. We therefore propose a pilot randomized study comparing Confirm Rx™ and Reveal LINQTM in the reliability and timeliness in data transmission.
- Conditions
- Cardiac Arrythmias, Syncope, Atrial Fibrillation, Atrial Flutter, Tachycardia, Stroke
- Being tested
- Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM
- Keywords
- Implantable Loop Recorder, Implantable Cardiac Monitor, Cryptogenic Stroke
- Medical subject headings
- Syncope, Atrial Fibrillation, Atrial Flutter, Tachycardia, Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTMDevice
Comparing reliability and timeliness in data transmission between two implantable cardiac monitors.
| Study group | Role | What they receive |
|---|---|---|
| Abbott, Inc Confirm Rx™ | Active comparator | Every other consenting subject will receive the Abbott Inc. Confirm Rx™ device. Receives: Device: Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM |
| Medtronic, Inc Reveal LINQTM | Active comparator | Every other consenting subject will receive the Medtronic, Inc. Reveal LINQTM. Receives: Device: Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from arrhythmic events to time of physician notification
Measured: 12 months
Time from activated events to time of physician notification
Measured: 12 months
Secondary outcomes (1)
Time from arrhythmic events to time of intervention if any
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 posted25 Oct 2018
- Study start18 May 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrythmiasStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sparrow Clinical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, John H. Ip, M.D., Sparrow Clinical Research Institute
- Investigators
- John H Ip, MD, Principal investigator, Sparrow Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720639
- Sponsor's protocol ID
- 41618
- Status last verified
- Mar 2020
- First submitted
- 24 Oct 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirm Rx™ Versus Reveal LINQ™ -Which is More Reliable in Data Transmission? A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03720639
- Acronym / sponsor ID
- 41618
- Conditions
- Cardiac Arrythmias, Syncope, Atrial Fibrillation, Atrial Flutter, Tachycardia, Stroke
- Keywords
- Implantable Loop Recorder, Implantable Cardiac Monitor, Cryptogenic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Sparrow Clinical Research InstituteUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 18 May 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder.
Detailed description
Implantable cardiac monitor (ICM) is an invaluable tool for diagnosing cardiac arrhythmia (1). Cryptogenic stroke, unexplained syncope and arrhythmia diagnosis are the most common indication for long term cardiac monitoring device. (2, 3). Reveal LINQTM (Medtronic, Inc.) is widely used for all of these purposes in the country. We have previously reported the use of Reveal XT in the use of atrial fibrillation (AF) surveillance in patient's post-AF ablation (2). We indicated that ICM is useful in long term monitoring of atrial arrhythmia in patients at risk of atrial fibrillation. Crystal AF (4) study also showed the importance of using ICM in detecting occult AF in patients with cryptogenic stroke in a timely manner so that appropriate treatment can be prescribed. The key to the success of ICM rest on how timely and reliable the ICM data can be transmitted to physician's office immediately after an arrhythmic events so the data can be analyzed and treatment rendered. Reveal LINQTM data transmission consists of two steps: 1. Data needs to be download into the MyCareLink™ monitor (scheduled daily at 2 am in the morning and monitor needs to be in the within 6 feet proximity of the patient) 2. MyCareLink™ monitor to be connected to the 3 G cellular network for the data transmission. (Fig 1). In cases of patient activated events, data transmission utilizes similar pathway.
We have reported significant delay in data transmission in the Reveal LINQTM occurs frequently and failure to connect among the Reveal LINQTM, MyCareLink™ monitor and the cellular network is the main reason for data transmission disruption and critical data could be concealed for an extended periods. To illustrate the importance of timely transmission of patient data, a Reveal LINQTM was implanted in a 54-year-old gentle man with past medical history of recurrent syncope. On 8/12/2017 the patient developed new onset dizziness and 6 seconds sinus pause was recorded by the device. However, a connection problem of MyCarelinkTM system made data unavailable until next scheduled office visit on 11/15/2017. The physician was notified on the same day and a pacemaker was implanted on the following day, almost 3 months after his significant arrhythmic events.
The newer generation of ICM such as Confirm Rx™ (Abbott, Inc) is connected directly to a patient's existing smartphone using the Bluetooth technology. By allowing patients to record and transmit symptoms with the mobile app, Confirm Rx™ ICM brings continuous remote monitoring to patients without the need for a home-based monitor (Fig 2). It is unclear which technologies offers faster and more reliable transmission of critical patient information to physician office so timely treatment can be provided. We therefore propose a pilot randomized study comparing Confirm Rx™ and Reveal LINQTM in the reliability and timeliness in data transmission.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbott, Inc Confirm Rx™ | Active comparator | Device: Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTMEvery other consenting subject will receive the Abbott Inc. Confirm Rx™ device. |
| Medtronic, Inc Reveal LINQTM | Active comparator | Device: Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTMEvery other consenting subject will receive the Medtronic, Inc. Reveal LINQTM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is 18 years of age or older
- Patient is willing and able to provide written informed consent
- Patient is willing and able to comply with the protocol, including follow-up visits and MyCareLink™ and Merlin™ transmissions (standard of care)
- Candidates for implantable cardiac monitor
Key exclusion criteria (3 listed)
- Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a study manager
- Patient has existing IPG, ICD, CRT-D or CRT-P device
- Adequate sensing in one week post implant. If sensing not adequate, patient will be in the registry.
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 |
|---|---|---|
| Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTMComparing reliability and timeliness in data transmission between two implantable cardiac monitors. | Device | Abbott, Inc Confirm Rx™, Medtronic, Inc Reveal LINQTM |
Primary outcome
Time from arrhythmic events to time of physician notification
Time frame: 12 months
Time from activated events to time of physician notification
Time frame: 12 months
1 secondary outcome
Time from arrhythmic events to time of intervention if any
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: No
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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.
John H Ip, MD principal investigator
Sparrow Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM in people with Cardiac Arrythmias and Syncope, run by Sparrow Clinical Research Institute at 2 sites in United States.
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 4 inclusion and 3 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 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from arrhythmic events to time of physician notification (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.