What is the DEFINE AFib Research Study?

The DEFINE AFib study is a prospective, observational, post-market clinical study. This nationwide, app-based study — sponsored by Medtronic — includes approximately 5,000 patients with a self-reported history of Afib and either a Reveal LINQ™ or LINQ II insertable cardiac monitor (ICM).

We will use our research findings to improve the understanding of how data from the LINQ Family of ICMs can be used to guide the management of Afib patients.

The study uses a combination of device data, electronic health records, and Apple® Health app data to evaluate the association between complex patterns of Afib and clinical outcomes and quality of life.

  

Primary Objective

To understand the association between summary and episodic measures of Afib and healthcare utilization.

Ancillary Objectives

  • Evaluate how clinical actions impact summary and episodic measures and Afib-related healthcare utilization.
  • Understand the association between Afib and quality of life.
  • Characterize patient preferences for interacting with their device data.
Three screenshots from the DEFINE AFib research study showing the study description and atrial fibrillation duration

Who is Eligible?

Eligible patients must meet the following criteria:

  • Self-reported virtual CHA2DS2-VASc score ≥ 2 for men and ≥ 3 for women
  • Have a Reveal LINQ or LINQ II ICM for the following device-logged indications, categorized into the following discrete groups:
    • Stroke: cryptogenic stroke indication
    • Afib management: Afib management and post-ablation management indications 
    • Suspected Afib: suspected Afib and palpitations indications
  • Self-reported history of Afib
  • Apple iPhone® 6S or above with iOS version 13 or later 
  • At least 22 years of age
  • Located in the United States
  • Valid email address
  • Read and write English

Additional criteria may apply.

Female physician wearing a white coat and stethoscope

Why Should I Refer Patients?

By referring patients to the study, you will help us gather the crucial data needed to help us improve patient care. This data could help uncover insights that better guide the management of Afib and help you improve your patients' outcomes now and in the future. In addition, physicians are compensated for their time spent recruiting patients. 

How Do I Enroll My Patients?

We made it easy to enroll in the DEFINE AFib research study.

Start by downloading the Medtronic Discovery app from the Apple® App Store®, or click the link below.

  

What Are My Responsibilities?

Encourage your patients who meet the study criteria to download the Medtronic Discovery app and start the DEFINE AFib screening survey.

Medtronic takes care of the rest, making DEFINE AFib a low burden study for you and your practice.

Medtronic supports patients 24/7 through a help desk at 833-833-8321.

Male patient and female healthcare professional looking at a tablet

What Data Is Collected?

Three data collection screenshots from the DEFINE AFib research study showing Afib duration, health access, and survey data

1. Clinical Data Collection

  • Medtronic LINQ Data
    Afib burden, Afib patterns, ECG morphology
  • Health Records
    Medications, procedures, conditions

2. Apple Health App-based Collection (when available) 

  • Fitness
    Exercise
  • Health
    Sleep tracking, activity (step count), weight, height, calculated BMI, glucose, nutrition, blood pressure, oxygen saturation
  • And More
    Additional variables depending upon patient authorization

3. Survey Data Collection

  • Patient-reported Outcomes
    Clinical events, symptoms, medications, medication adherence, quality of life
  • Treatment-focused Outcomes
    Clinical actions, change in treatment, healthcare utilization

What Is the Process for the Study?

  1. Participants with a Reveal LINQ or LINQ II device + iPhone opt in
  2. App collects health data, symptoms, medication use and compliance, clinical events, and clinical actions, and provides patients with their device data
  3. Surveys are utilized to understand patient experience with app
  4. Identify relevant Afib patterns/burden associated with healthcare utilization and other clinical events
Process for the DEFINE AFib research study

What is Required of My Patients?

  • Once they enter the study, they'll be prompted to respond to a brief health questionnaire and surveys on quality-of-life metrics.
  • They will be asked to fill out a survey like the ones pictured to help us understand their interaction with your healthcare system, such as a clinic visit.
  • From time to time, we will ask them about their Afib symptoms throughout the study. 
  • Survey data will not be available to physicians for review.
 

What ICM Data Will My Patient Have Access To?

They’ll have special access to data from their Reveal LINQ or LINQ II device that shows their average Afib duration.

  • Select Week or Month to see the average daily or weekly total of the amount of time they were in Afib, and daily total for each individual day of that week or month.
  • ICM data is shown in 15-minute increments to reduce the chance that a patient will be shown potentially false positive episodes, but this could still occur.

Disclaimer: The display of device data on the app is not intended to be a substitute for medical diagnosis or treatment. The device data displayed on the app may not be reviewed by the healthcare provider.

  

Three screenshots from the DEFINE AFib research study showing required patient questionnaire and surveys
Screenshots from the DEFINE AFib research study showing data that patients can access including average Afib duration

Patient Recruitment Resources

Download patient materials here:

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All patient data depicated in the app images above is fictitious and for demonstration purposes only.

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