DEFINE AFib Research Study Enrollment Steps and FAQ

Getting Started — Enrollment Steps

Frequently Asked Questions (FAQ)

What is an Observational Study?

An observational study is where researchers observe the effect of a risk factor, such as atrial fibrillation (Afib) burden, treatment, or other intervention on a person's quality of life. The goal of an observational study is to obtain a snapshot of specific characteristics of an individual, group, or setting, and to understand cause and effect.

What is the Goal of the Define AFib Research Study?

The DEFINE AFib research study aims to improve the understanding of how data from the Reveal LINQ^™ and LINQ II^™ insertable cardiac monitors (ICMs) can be used to guide the management of Afib patients.

We will use a combination of device data, electronic health records, and Health app data to evaluate the association between complex patterns of Afib and clinical outcomes, quality of life, and healthcare visits.

Who Can Participate in the Define AFib Study?

You may be eligible if you:

• Have a Medtronic Reveal LINQ or LINQ II ICM
• Have a history of Afib
• Have an Apple iPhone^® 6s or newer device with iOS version 13 or later
• Both speak and read English
• Have a self-reported CHA₂DS₂-VASc score of ≥ 2 for men and ≥ 3 for women calculated within the app during enrollment process
• Are aged 22 years or older
• Have a valid email address
• Are located in the United States
• Are willing to comply with the protocol, including CL transmissions

What Can I Expect if I Participate?

The DEFINE AFib research study lasts for 3–5 years. Below is a high-level summary of what you can expect if you participate in the research study.

Note: As a volunteer participant, you can exit the study at any time.

Screening and Consent

Before enrolling in the study, you will answer a few screening questions through the app. These questions will determine your eligibility to participate. If it is determined you are a good candidate to enroll, you will be asked to sign a consent form in the app to participate.

Survey Period

Once the study begins, you will be asked to respond to several short surveys each month for 3–5 years.

Will I be Paid for Being in This Study?

Subjects are paid $25 every six months for completing at least 75% of their study tasks. The payment will be sent as an electronic gift card.

How Will My Information be Used?

To participate in the research study, you will need to sign a consent form through the app. If you decide to participate in the research study, Medtronic (including its agents and contractors) and others who work with the research study will see health information about you.

Medtronic will keep your health information confidential in accordance with all applicable laws and regulations. Any reports or publications about the research study or any other research will not include your name or a description of you. Information received during the research study will not be used to market to you; your name will not be placed on any marketing mailing lists or sold to anyone for marketing purposes.

What do I do if I Want to Participate?

If you’re interested in participating, please download our free Medtronic Discovery app.

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