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DEFINE AFib is a prospective, observational, post-market clinical study administered to patients via the Medtronic Discovery app platform. This study will enroll approximately 5,000 patients in the United States who have a Reveal LINQ or LINQ II ICM (or future market-released LINQ devices) and an Apple® iPhone® with iOS version 13 or higher. Interested participants will be screened through the Medtronic Discovery app and those eligible will complete an app-based informed consent. Participants will receive health-focused and quality of life surveys at variable timepoints. DEFINE AFib will measure healthcare interactions using administered surveys to identify said interactions. The Medtronic Discovery app will provide participants with a summary of their ICM data. Participants will be followed up to 5 years or to the end of their ICM service life.
The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the market- released LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. The Medtronic Discovery app will be used to collect data both (1) via the iPhone® through patient-reported health surveys and Bluetooth-enabled devices connected through the Apple Health app and (2) data accessed through or stored on the phone pertaining to health records, activity, and other lifestyle data. Secondarily, this study will examine associations between clinical procedures, medications and lifestyle actions taken and their impact on device-detected AF. Additionally, this study will help Medtronic evaluate patients' interaction with reports generated from health data collected by the market-released LINQ ICM. This study will improve our understanding of how data from the LINQ family of devices can be used to guide the management of AF patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction. | Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction. A predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC. | Through study completion (2 years of enrollment, up to 2.6 years of follow-up) |
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Inclusion Criteria
Patients with a LINQ ICM who have a self-reported history of AF and who have received an ICM for the following device-logged indications, categorized into the following discrete groups:
Individual Access and ability to use an Apple iPhone® compatible with Medtronic's research app (iOS® v. 13.X or higher)
Patient is willing and able to comply with the protocol, including CareLink transmissions (requires adequate connectivity), remotely administered instructions, and remote survey participation
Patient is 22 years of age or older
Located in the United States, with CareLink managed through servers located in United States (50 states or District of Columbia)
Valid email address from self-report at enrollment
Patient must be able to read and write in English
Exclusion Criteria Patients with > 24 months elapsed time from recorded LINQ device implant or > 48 months elapsed from recorded LINQ II implant date
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Patients with Atrial Fibrillation and a LINQ device
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Piccini, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Joseph Heritage Hospital | Mission Viejo | California | 92691 | United States | ||
| Desert Heart Rhythm Consultants |
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During study execution, there was a sponsor decision to end the study earlier, so the study enrolled far less than the 5000 enrollments specified by the protocol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enrolled Patients | Patients that completed a survey on the study App that confirmed that they met the inclusion/exclusion criteria of the study and that they read and agreed with the informed consent. |
| 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 | Jul 29, 2022 | Nov 7, 2024 |
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| Palm Springs |
| California |
| 92262 |
| United States |
| Florida Electrophysiology Associates | Atlantis | Florida | 33462-6614 | United States |
| Cardiac Arrhythmia Service | Boca Raton | Florida | 33432 | United States |
| University of Florida Health Shands Hospital | Gainesville | Florida | 32610 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| HCA Healthcare | Overland Park | Kansas | 66211 | United States |
| Stormont Vail Health Cotton O'Neil Clinical Research Center | Topeka | Kansas | 66606 | United States |
| Norton Heart Specialists | Louisville | Kentucky | 40241 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| The Valley Hospital | Ridgewood | New Jersey | 07450-2726 | United States |
| New York Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Huntington Hospital | Huntington | New York | 11743 | United States |
| NYU Langone Hospital Long Island | Mineola | New York | 11501 | United States |
| White Plains Hospital Medical Center | White Plains | New York | 10601 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cone Health | Greensboro | North Carolina | 27401 | United States |
| Oklahoma Heart Hospital Research Foundation | Oklahoma City | Oklahoma | 73120 | United States |
| St. Luke's Cardiology Associates | Bethlehem | Pennsylvania | 18018 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Stern Cardiovascular Foundation | Germantown | Tennessee | 38138 | United States |
| Ascension Seton Heart Institute Clinical Research | Austin | Texas | 78705 | United States |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Due to eligibility survey responses permanently missing for 3 subjects, 970 of the 973 subject enrollments are included in all analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | Patients that completed a survey on the study App that confirmed that they met the inclusion/exclusion criteria of the study and that they read and agreed with the informed consent. |
| 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 |
| |||||||||||||||||||||||
| 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 |
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| Reason for enrollment | Patients in the study received a LINQ device for one of the following reasons: AF ablation, AF management, cryptogenic stroke, palpitations or suspected AF | 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 | Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction. | Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction. A predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC. | Posted | Number | 95% Confidence Interval | Proportion | Through study completion (2 years of enrollment, up to 2.6 years of follow-up) |
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All cause mortality was monitored from time of enrollment to completion of study (up to 2.6 years of follow-up). Adverse events were not required and were not collected to meet the objectives of this study.
All cause mortality was monitored, but adverse events were not required and were not collected to meet the objectives of this study.
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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 | Enrolled Patients | Patients that completed a survey on the study App that confirmed that they met the inclusion/exclusion criteria of the study and that they read and agreed with the informed consent. | 9 | 970 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nirav Patel | Medtronic | 1 (800) 633-8766 | nirav.a.patel@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 10, 2023 | Nov 6, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| 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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| Cryptogenic Stroke |
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| Palpitations |
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| Suspected AF |
|