Arrhythmias, CardiacNCT02746471
Reveal LINQ Registry
An observational study of Arrhythmias, Cardiac, run by Medtronic Cardiac Rhythm and Heart Failure at 48 sites in 9 countries.
Trial summary
The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Reveal LINQ
- Type of treatment
- Medical device
- How many people
- 1,604 participants
- Where
- 48 sitesin 9 countries
- Study dates
- Apr 2014to 4 Jun 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients intended to receive a market-released Reveal LINQ device are eligible to enroll in the Registry. All enrolled patients that have an attempted procedure will be included in the analysis. Consented patients who failed to receive a Reveal LINQ device may be exited from the registry when all reportable events are resolved.
Who may be able to join
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
- Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
- Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
- Subject consent prior to ICM insertion
Who cannot join
- Subject who is, or is expected to be inaccessible for follow-up
- Subject with exclusion criteria required by local law
- Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
United States19 sites
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Baylor Research Institute (Dallas-TX)
Dallas, Texas, 75206
Geisinger Medical Center
Danville, Pennsylvania, 17822
Iowa Heart Center
Des Moines, Iowa, 50314
Baylor Research Institute (Fort Worth TX)
Fort Worth, Texas, 76104-4110
Jacksonville Heart (Baptist Medical)
Jacksonville, Florida, 32207
Saint Lukes Health System
Kansas City, Missouri, 64111-3220
Aurora Cardiovascular Services
Milwaukee, Wisconsin, 53215
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121-2429
NYU Langone Medical Center
New York, New York, 10016-4303
Baylor Research Institute (Plano TX)
Plano, Texas, 75093-3691
The Valley Hospital
Ridgewood, New Jersey, 07450
University of California San Francisco UCSF Medical Center
San Francisco, California, 94143-0138
Washington University School of Medicine
St Louis, Missouri, 63110
Washington Adventist Hospital
Takoma Park, Maryland, 20912-6367
Bay Heart Group
Tampa, Florida, 33607
Japan14 sites
National Kyushu Medical Center
Fukuoka, 810-8563
Saitama Medical University International Medical Center
Hidaka, 350-1298
Hirosaki University Hospital
Hirosaki, 036-8563
Hospital of the University of Occupational and Environmental Health
Kitakyushu, 807-8556
Saiseikai Kumamoto Hospital
Kumamoto, 861-4193
Kyorin University Hospital
Mitaka, 181-8611
Iwate Medical University Hospital
Morioka, 020-8505
Ogaki Municipal Hospital
Ōgaki, 503-8502
Okayama University Hospital
Okayama, 700-8558
Showa University Hospital
Shinagawa-Ku, 142-8555
National Cerebral and Cardiovascular Center
Suita, 565-8565
The Jikei University School of Medicine Hospital
Tokyo, 105-8471
Toho University Omori Medical Center
Tokyo, 143-8541
Fujita Health University Hospital
Toyoake, 470-1192
Portugal6 sites
Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz
Carnaxide
Hospital Senhora da Oliveira, Guimaraes
Guimarães
Centro Hospitarlar Lisboa Norte - Hospital de Santa Maria
Lisbon
Hospital do Espirito Santo
Ponta Delgada
Centro Hospitalar do Porto - Hospital de Santo Antonio
Porto
Hospital Distrital de Santarem
Santarém
Italy2 sites
Ospedale classificato ed equiparato Sacro Cuore
Negrar
Presidio Ospedaliero Santa Maria del Carmine
Rovereto, 38068
Netherlands2 sites
Catharina Ziekenhuis
Eindhoven
Maastricht Universitair Medisch Centrum (MUMC)
Maastricht
Saudi Arabia2 sites
King Fahd Armed Forces Hospital
Jeddah, 21159
Prince Sultan Cardiac Center
Riyadh
About this study
Official title: Medtronic Reveal LINQ Insertable Cardiac Monitor Registry
The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
Read the detailed description
The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 36 months.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Reveal LINQ
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reveal LINQDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature
Clinical actions taken over the course of study follow-up
Measured: Implant to 36 months post-implant
Number of Participants With Procedure-related Acute Infection Rate
Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection.
Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered.
Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered.
For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.
Measured: Implant to 30 days post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startApr 2014
- Primary completion4 Jun 2021
- Study completion4 Jun 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suneet Mittal, M.D., Principal investigator, The Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746471
- Sponsor's protocol ID
- Reveal LINQ Registry
- Status last verified
- Mar 2022
- First submitted
- 29 Feb 2016
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Beinart SC, Natale A, Verma A, Amin A, Kasner S, Diener HC, Del Greco M, Wilkoff BL, Pouliot E, Franco N, Mittal S. Real-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory. Am Heart J. 2019 Jan;207:76-82. doi: 10.1016/j.ahj.2018.10.002. Epub 2018 Oct 14.
PubMed 30487072
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Reveal LINQ Insertable Cardiac Monitor Registry
- ClinicalTrials.gov ID
- NCT02746471
- Acronym / sponsor ID
- Reveal LINQ Registry
- Conditions
- Arrhythmias, Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,604 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Apr 2014 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 Jun 2021 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
Detailed description
The study is a prospective, non-randomized, observational, multi-center, global study. The study will characterize clinical actions initiated by Reveal LINQ arrhythmia detection and estimate procedure-related acute infection rate. Approximately 1,500 subjects will be implanted with a Reveal LINQ ICM and undergo continuous remote monitoring and be followed prospectively from insertion through 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients intended to receive a market-released Reveal LINQ device are eligible to enroll in the Registry. All enrolled patients that have an attempted procedure will be included in the analysis. Consented patients who failed to receive a Reveal LINQ device may be exited from the registry when all reportable events are resolved.
Key inclusion criteria (4 listed)
- Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
- Subject is intended to receive or be treated with the have a Reveal LINQ ICM inserted in the next 30 days.
- Patient enrolled before or on the same date of insertion of the Reveal LINQ ICM
- Subject consent prior to ICM insertion
Key exclusion criteria (3 listed)
- Subject who is, or is expected to be inaccessible for follow-up
- Subject with exclusion criteria required by local law
- Subject is currently enrolled in or plans to enroll a concurrent study that may confound the results of this study. Co-enrollment in any concurrent drug and/or device clinical study (including registries) requires approval of the study manager or designee.
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 |
|---|---|---|
| Reveal LINQ | Device | – |
Primary outcome
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature
Time frame: Implant to 36 months post-implant
Clinical actions taken over the course of study follow-up
Number of Participants With Procedure-related Acute Infection Rate
Time frame: Implant to 30 days post-implant
Acute infection rate in the subjects who were followed for at least 30 days or had an infection prior to 30 days. Infections are as assessed by the Investigator and defined as deep incision site or superficial infection. Deep incision site are classified as pain, redness, or drainage at incision site requiring the device to be removed or IV antibiotics administered. Superficial infections are defined as redness beyond procedure expectation and oral antibiotics administered. For both deep incision and superficial infections, a physician directed intervention must occur for the event to be defined as an infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30487072Beinart SC, Natale A, Verma A, Amin A, Kasner S, Diener HC, Del Greco M, Wilkoff BL, Pouliot E, Franco N, Mittal S. Real-world comparison of in-hospital Reveal LINQ insertable cardiac monitor insertion inside and outside of the cardiac catheterization or electrophysiology laboratory. Am Heart J. 2019 Jan;207:76-82. doi: 10.1016/j.ahj.2018.10.002. Epub 2018 Oct 14.
- Individual participant dataSharing planned: Undecided
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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.
Suneet Mittal, M.D. principal investigator
The Valley Hospital
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac, run by Medtronic Cardiac Rhythm and Heart Failure at 48 sites in 9 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 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 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Japan, Portugal, Italy, Netherlands and 4 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 18 Jul 2022). 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?
Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature (time frame: Implant to 36 months post-implant). 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?
On the ClinicalTrials.gov record for NCT02746471, which also lists 1 linked publication.
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 18 Jul 2022.