DEFINE AFib (Atrial Fibrillation)

Part of paid clinical trials in Mission Viejo, California.

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Study ID
NCT04926857
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-Interventional — OTHER
    Non-Interventional

Study Details

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.

Key Dates

Start date
Jun 21, 2021
Status verified
Jul 2025
Primary completion
Jan 25, 2024
Completion
Jan 25, 2024

Study Design

Enrollment
973 participants (actual)

Primary Outcome Measure

Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction. [ Time Frame: Through study completion (2 years of enrollment, up to 2.6 years of follow-up) ]

Locations (26)

FacilityCityStateZIPSite coordinators
Saint Joseph Heritage HospitalMission ViejoCalifornia92691-
Desert Heart Rhythm ConsultantsPalm SpringsCalifornia92262-
Florida Electrophysiology AssociatesAtlantisFlorida33462-6614-
Cardiac Arrhythmia ServiceBoca RatonFlorida33432-
University of Florida Health Shands HospitalGainesvilleFlorida32610-
Northwestern UniversityChicagoIllinois60611-
University of Kansas Medical CenterKansas CityKansas66160-
HCA HealthcareOverland ParkKansas66211-
Stormont Vail Health Cotton O'Neil Clinical Research CenterTopekaKansas66606-
Norton Heart SpecialistsLouisvilleKentucky40241-
Massachusetts General HospitalBostonMassachusetts02114-
Jackson Heart ClinicJacksonMississippi39216-
Cooper University HospitalCamdenNew Jersey08103-
The Valley HospitalRidgewoodNew Jersey07450-2726-
New York Presbyterian Brooklyn Methodist HospitalBrooklynNew York11215-
Huntington HospitalHuntingtonNew York11743-
NYU Langone Hospital Long IslandMineolaNew York11501-
White Plains Hospital Medical CenterWhite PlainsNew York10601-
Duke University Medical CenterDurhamNorth Carolina27710-
Cone HealthGreensboroNorth Carolina27401-
Oklahoma Heart Hospital Research FoundationOklahoma CityOklahoma73120-
St. Luke's Cardiology AssociatesBethlehemPennsylvania18018-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
Stern Cardiovascular FoundationGermantownTennessee38138-
Ascension Seton Heart Institute Clinical ResearchAustinTexas78705-
PeaceHealth Saint Joseph Medical CenterBellinghamWashington98225-

Find similar trials in Mission Viejo, CA

By condition
Atrial fibrillation
By specialty
CardiologyHeart disease
By research site
Saint Joseph Heritage Hospital· Mission Viejo, CADesert Heart Rhythm Consultants· Palm Springs, CAFlorida Electrophysiology Associates· Atlantis, FLCardiac Arrhythmia Service· Boca Raton, FLUniversity of Florida Health Shands Hospital· Gainesville, FLNorthwestern University· Chicago, IL

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