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(352) 733-0111

DEFINE

  • Status
    Accepting Candidates
  • Age
    22 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

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.

Details

Full study title DEFINE AFib
Protocol number OCR41884
ClinicalTrials.gov ID NCT04926857

Eligibility

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

Lead researcher

  • Kun "Kevin" Xiang, MD, PhD
    Cardiologist (Heart Specialist), Clinical Cardiologist - Electrophysiology Specialist
    Kun "Kevin" Xiang

Participate in a study

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.