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The Reveal LINQ Registry will generate reliable long-term "real world" data of product performance, economic valuation, site-of-service procedural information.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal LINQ | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Clinical actions taken over the course of study follow-up | 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. | Implant to 30 days post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Suneet Mittal, M.D. | The Valley Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco UCSF Medical Center | San Francisco | California | 94143-0138 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30487072 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Registry | 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2016 | Nov 19, 2021 |
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| Jacksonville Heart (Baptist Medical) |
| Jacksonville |
| Florida |
| 32207 |
| United States |
| Bay Heart Group | Tampa | Florida | 33607 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50314 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121-2429 | United States |
| Washington Adventist Hospital | Takoma Park | Maryland | 20912-6367 | United States |
| Saint Lukes Health System | Kansas City | Missouri | 64111-3220 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | United States |
| NYU Langone Medical Center | New York | New York | 10016-4303 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| Baylor Research Institute (Dallas-TX) | Dallas | Texas | 75206 | United States |
| Baylor Research Institute (Fort Worth TX) | Fort Worth | Texas | 76104-4110 | United States |
| Baylor Research Institute (Plano TX) | Plano | Texas | 75093-3691 | United States |
| Aurora Cardiovascular Services | Milwaukee | Wisconsin | 53215 | United States |
| Ziekenhuis Oost Limburg - Campus St.-Jan | Leuven | Belgium |
| Evaggelismos Hospital | Athens | 10676 | Greece |
| The Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |
| Ospedale classificato ed equiparato Sacro Cuore | Negrar | Italy |
| Presidio Ospedaliero Santa Maria del Carmine | Rovereto | 38068 | Italy |
| National Kyushu Medical Center | Fukuoka | 810-8563 | Japan |
| Saitama Medical University International Medical Center | Hidaka | 350-1298 | Japan |
| Hirosaki University Hospital | Hirosaki | 036-8563 | Japan |
| Hospital of the University of Occupational and Environmental Health | Kitakyushu | 807-8556 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto | 861-4193 | Japan |
| Kyorin University Hospital | Mitaka | 181-8611 | Japan |
| Iwate Medical University Hospital | Morioka | 020-8505 | Japan |
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| Ogaki Municipal Hospital | ÅŒgaki | 503-8502 | Japan |
| Showa University Hospital | Shinagawa-Ku | 142-8555 | Japan |
| National Cerebral and Cardiovascular Center | Suita | 565-8565 | Japan |
| The Jikei University School of Medicine Hospital | Tokyo | 105-8471 | Japan |
| Toho University Omori Medical Center | Tokyo | 143-8541 | Japan |
| Fujita Health University Hospital | Toyoake | 470-1192 | Japan |
| Catharina Ziekenhuis | Eindhoven | Netherlands |
| Maastricht Universitair Medisch Centrum (MUMC) | Maastricht | Netherlands |
| Centro Hospitalar Lisboa Ocidental - Hospital de Santa Cruz | Carnaxide | Portugal |
| Hospital Senhora da Oliveira, Guimaraes | Guimarães | Portugal |
| Centro Hospitarlar Lisboa Norte - Hospital de Santa Maria | Lisbon | Portugal |
| Hospital do Espirito Santo | Ponta Delgada | Portugal |
| Centro Hospitalar do Porto - Hospital de Santo Antonio | Porto | Portugal |
| Hospital Distrital de Santarem | Santarém | Portugal |
| King Fahd Armed Forces Hospital | Jeddah | 21159 | Saudi Arabia |
| Prince Sultan Cardiac Center | Riyadh | Saudi Arabia |
| COMPLETED |
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| NOT COMPLETED |
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Subjects who had a LINQ device implanted.
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| ID | Title | Description |
|---|---|---|
| BG000 | LINQ Subjects | Subjects who were confirmed to have been implanted with a LINQ device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| NYHA | New York Heart Association (NYHA) classification for the stages of Heart Failure. Values range from I-IV. Higher values indicate more severe limitations in patient activity due to symptoms | Count of Participants | Participants |
| ||||||||||||||||||||||
| Reason for Implant | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number and Type of Clinical Actions Initiated by Reveal LINQ Arrhythmia Detection Feature | Clinical actions taken over the course of study follow-up | Subjects who had an opportunity to have an action taken after ICM insertion | Posted | Number | Number of times action taken | Implant to 36 months post-implant |
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| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | Same as arm/group description | Posted | Count of Participants | Participants | Implant to 30 days post-implant |
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Up to 36 months of study enrollment
Systematic Assessment: At follow-up visits subjects were asked about occurrence of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Registry | 1604 subjects were enrolled in the study from 55 centers in US, EMEA and Saudi Arabia. Follow-up data collection ended on 04 Jun 2021. | 43 | 1,604 | 64 | 1,604 | 0 | 1,604 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Anal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Atrioventricular block complete | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Brain stem haemorrhage | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Cerebellar haemorrhage | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Cerebral artery embolism | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Device dislocation | Product Issues | MedDRA (24.0) | Systematic Assessment |
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| Device expulsion | Product Issues | MedDRA (24.0) | Systematic Assessment |
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| Device extrusion | Product Issues | MedDRA (24.0) | Systematic Assessment |
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| Embolic stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Haemorrhage | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
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| Infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Pocket erosion | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Postoperative respiratory distress | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Sinus node dysfunction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
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| Ventricular extrasystoles | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
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In most cases, contracts allow investigators ("PI") to publish per the publication strategy/Clinical Investigation Plan following Medtronic's review for (a) disclosure of confidential information ("CI"), and (b) selection and order of publications by the publications committee. Any such CI is deleted prior to publication/presentation. Medtronic may not otherwise censor/interfere with the publication. PI's may not publish single-site data until the main multi-site publication has occurred.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erika Pouliot | Medtronic | 17635261270 | erika.pouliot@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 29, 2016 | Nov 22, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Netherlands |
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| Belgium |
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| United States |
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| Japan |
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| Italy |
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| Israel |
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| Portugal |
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| Germany |
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| United Kingdom |
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| Spain |
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| Class III |
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| Not Available |
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| Patient does not have Heart Failure |
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| Palpitations |
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| Post-AF Ablation Monitoring |
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| Pre-AF Ablation Monitoring |
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| Seizures |
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| Suspected AF |
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| Syncope |
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| Transient Ischemic Attack (TIA) |
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| Ventricular Tachycardia |
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| Other |
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| Title | Measurements |
|---|---|
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| PCI |
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| PFO Closure |
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| Therapeutic Device Implanted |
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| Aortic valve replacement |
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| Placement of a Watchman device |
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| Stopped OAC medication at least once during study (was on at baseline) |
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| Started OAC medication at least once during study (was off at baseline) |
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