DEFINE AFib (Atrial Fibrillation)

Medtronic

Status: Terminated

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.

Full description

The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the market- released LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. The Medtronic Discovery app will be used to collect data both (1) via the iPhone® through patient-reported health surveys and Bluetooth-enabled devices connected through the Apple Health app and (2) data accessed through or stored on the phone pertaining to health records, activity, and other lifestyle data. Secondarily, this study will examine associations between clinical procedures, medications and lifestyle actions taken and their impact on device-detected AF. Additionally, this study will help Medtronic evaluate patients' interaction with reports generated from health data collected by the market-released LINQ ICM. This study will improve our understanding of how data from the LINQ family of devices can be used to guide the management of AF patients.

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

Trial design