DEFINE AFib (Atrial Fibrillation) (DEFINE AFib)
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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 |
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Recruitment Status :
Recruiting
First Posted : June 15, 2021
Last Update Posted : April 28, 2022
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Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
- Study Details
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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 |
| 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
MedlinePlus Genetics related topics:
Familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
Intervention Details:
- Other: Non-Interventional
Non-Interventional
Primary Outcome Measures :
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
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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
| Contact: Nancy Mcclelland, RN, BSN, CHFN | 17635261284 | nancy.l.mcclelland@medtronic.com | |
| Contact: Cody Johnson, PhD | 17635262299 | cody.c.johnson@medtronic.com |
Locations
Show 20 study locations
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
| 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 |
| 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 |