Clinical trial NCT04926857: DEFINE AFib (Atrial Fibrillation)
Official title: DEFINE AFib Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 973
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Atrial Fibrillation and a LINQ device

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Healthcare Utilization where AF was a reason or a suspected reason for the healthcare interaction.
timeFrame: Through study completion (2 years of enrollment, up to 5 years of follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: Saint Joseph Heritage Hospital
state: California
city: Palm Springs
country: United States
facility: Desert Heart Rhythm Consultants
state: California
city: Atlantis
country: United States
facility: Florida Electrophysiology Associates
state: Florida
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Service
state: Florida
city: Gainesville
country: United States
facility: University of Florida Health Shands Hospital
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Overland Park
country: United States
facility: HCA Healthcare
state: Kansas
city: Topeka
country: United States
facility: Stormont Vail Health Cotton O'Neil Clinical Research Center
state: Kansas
city: Louisville
country: United States
facility: Norton Heart Specialists
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New York Presbyterian Brooklyn Methodist Hospital
state: New York
city: Huntington
country: United States
facility: Huntington Hospital
state: New York
city: Mineola
country: United States
facility: NYU Langone Hospital Long Island
state: New York
city: White Plains
country: United States
facility: White Plains Hospital Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation
state: Oklahoma
city: Bethlehem
country: United States
facility: St. Luke's Cardiology Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Austin
country: United States
facility: Ascension Seton Heart Institute Clinical Research
state: Texas
city: Bellingham
country: United States
facility: PeaceHealth Saint Joseph Medical Center
state: Washington
Study officials:
References: