DEFINE AFib (Atrial Fibrillation)

Medtronic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT04926857

MDT20024

Details and patient eligibility

About

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.

Enrollment: 973 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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