CB- AFib – Observational Study

DEFINE AFib is a prospective, observational, non-significant risk 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.

You may be eligible to participate in this study if you:

  • 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:
    • Stroke: Cryptogenic stroke indication
    • AF management: AF management and post-ablation management indications
    • Suspected AF: Suspected AF and palpitations indications
  • Individual Access and ability to use an Apple iPhone® compatible with Medtronic’s research app (iOS® 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
  • Self-reported virtual CHA2DS2-VASc score ≥2 for men and ≥3 for women
  • 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

You may NOT participate in this study if you:

  • Have > 24 months elapsed time from recorded LINQ device implant or > 48 months elapsed from recorded LINQ II implant date

Contact Information

Martha Ferrara, Study Coordinator

41 E Post Road White Plains, NY 10601
Phone: (914) 849-2690
Email: mferrara3@wphospital.org