Atrial Fibrillation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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: * AF management: AF management and post-ablation management indications * Suspected AF: Suspected AF and palpitations indications * Stroke: Cryptogenic stroke indication * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction. | Through study completion (2 years of enrollment, up to 2.6 years of follow-up) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 970 |
| Total | 970 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Inadequate data to address primary objective | 16 |
| Overall Study | Study product no longer in use | 44 |
| Overall Study | Withdrawal by Subject | 40 |
Baseline characteristics
| Characteristic | Enrolled Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 694 Participants |
| Age, Categorical Between 18 and 65 years | 276 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 22 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 136 Participants |
| Race (NIH/OMB) White | 777 Participants |
| Reason for enrollment AF Ablation | 181 Participants |
| Reason for enrollment AF Management | 584 Participants |
| Reason for enrollment Cryptogenic Stroke | 91 Participants |
| Reason for enrollment Palpitations | 20 Participants |
| Reason for enrollment Suspected AF | 94 Participants |
| Region of Enrollment United States | 970 participants |
| Sex: Female, Male Female | 414 Participants |
| Sex: Female, Male Male | 556 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 970 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Through study completion (2 years of enrollment, up to 2.6 years of follow-up)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training and Testing Partitions | Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction. | 0.76 Proportion |