DEFINE AFib (Atrial Fibrillation)
Megadott ok: Business decision
Key facts
- Where
- Atlantis, Austin, Bellingham, Bethlehem, Boca Raton, Boston, Brooklyn, Camden, Chicago, Durham, Gainesville, Germantown, Greensboro, Huntington, Jackson, Kansas City, Louisville, Mineola, Mission Viejo, Oklahoma City, Overland Park, Palm Springs, Philadelphia, Ridgewood, Topeka és White Plains, Egyesült ÁllamokSee the 26 sites
Where in Egyesült Államok
- Florida Electrophysiology AssociatesAtlantis, Egyesült ÁllamokNo longer taking part
- Ascension Seton Heart Institute Clinical ResearchAustin, Egyesült ÁllamokNo longer taking part
- PeaceHealth Saint Joseph Medical CenterBellingham, Egyesült ÁllamokNo longer taking part
- St. Luke's Cardiology AssociatesBethlehem, Egyesült ÁllamokNo longer taking part
- Cardiac Arrhythmia ServiceBoca Raton, Egyesült ÁllamokNo longer taking part
- Massachusetts General HospitalBoston, Egyesült ÁllamokNo longer taking part
- New York-Presbyterian/Brooklyn Methodist HospitalBrooklyn, Egyesült ÁllamokNo longer taking part
- Cooper University HospitalCamden, Egyesült ÁllamokNo longer taking part
- Northwestern UniversityChicago, Egyesült ÁllamokNo longer taking part
- Duke University Medical CenterDurham, Egyesült ÁllamokNo longer taking part
- University of Florida Health Shands HospitalGainesville, Egyesült ÁllamokNo longer taking part
- Stern Cardiovascular FoundationGermantown, Egyesült ÁllamokNo longer taking part
- Cone HealthGreensboro, Egyesült ÁllamokNo longer taking part
- Huntington HospitalHuntington, Egyesült ÁllamokNo longer taking part
- Jackson Heart ClinicJackson, Egyesült ÁllamokNo longer taking part
- University of Kansas Medical CenterKansas City, Egyesült ÁllamokNo longer taking part
- Norton Heart SpecialistsLouisville, Egyesült ÁllamokNo longer taking part
- NYU Langone Hospital - Long IslandMineola, Egyesült ÁllamokNo longer taking part
- Saint Joseph Heritage HospitalMission Viejo, Egyesült ÁllamokNo longer taking part
- Oklahoma Heart Hospital Research FoundationOklahoma City, Egyesült ÁllamokNo longer taking part
- HCA HealthcareOverland Park, Egyesült ÁllamokNo longer taking part
- Desert Heart Rhythm ConsultantsPalm Springs, Egyesült ÁllamokNo longer taking part
- Hospital of the University of PennsylvaniaPhiladelphia, Egyesült ÁllamokNo longer taking part
- The Valley HospitalRidgewood, Egyesült ÁllamokNo longer taking part
- Stormont Vail Health Cotton O'Neil Clinical Research CenterTopeka, Egyesült ÁllamokNo longer taking part
- White Plains Hospital Medical CenterWhite Plains, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Medtronic Cardiac Rhythm and Heart Failure
- Trial code
- NCT04926857
- Record updated
- 2025. augusztus 1.
- Original description
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.Read full original descriptionShow less
DEFINE AFib Atrial Fibrillation - Development of a Predictive Model for Future Health Care Utilization From Measurements Collected From an Implantable Cardiac Monitor.
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.
Inclusion: 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.