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DEFINE AFib (Atrial Fibrillation) (DEFINE AFib)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04926857
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

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.

Condition or disease Intervention/treatment
Atrial Fibrillation Other: Non-Interventional

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DEFINE AFib Atrial Fibrillation
Actual Study Start Date : June 21, 2021
Estimated Primary Completion Date : June 2028
Estimated Study Completion Date : August 2028

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Non-Interventional
    Non-Interventional


Primary Outcome Measures :
  1. 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 5 years of follow-up) ]
    Primary objective is to evaluate whether summary and episodic measurements collected by market-released LINQ ICMs are able to predict increased AF-related healthcare utilization (HCU), which are confirmed healthcare visits in the inpatient hospital, outpatient hospital, clinic/office, emergency department, or other care location (including remote visits) where AF was a reason or suspected reason for healthcare interaction.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Atrial Fibrillation and a LINQ device
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:

    • Stroke: Cryptogenic stroke indication
    • AF management: AF management and post-ablation management indications
    • Suspected AF: Suspected AF and palpitations indications
  • 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
  • Self-reported virtual CHA2DS2-VASc score ≥2 for men and ≥3 for women
  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926857


Contacts
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Contact: Nancy Mcclelland, RN, BSN, CHFN 17635261284 nancy.l.mcclelland@medtronic.com
Contact: Cody Johnson, PhD 17635262299 cody.c.johnson@medtronic.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT04926857    
Other Study ID Numbers: MDT20024
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes