Atrial FibrillationDEFINE AFibNCT04926857
DEFINE AFib (Atrial Fibrillation)
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Non-Interventional
- How many people
- 973 participants
- Where
- 26 sitesUnited States
- Study dates
- 21 Jun 2021to 25 Jan 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Atrial Fibrillation and a LINQ device
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Florida Electrophysiology Associates
Atlantis, Florida, 33462-6614
Ascension Seton Heart Institute Clinical Research
Austin, Texas, 78705
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
St. Luke's Cardiology Associates
Bethlehem, Pennsylvania, 18018
Cardiac Arrhythmia Service
Boca Raton, Florida, 33432
Massachusetts General Hospital
Boston, Massachusetts, 02114
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215
Cooper University Hospital
Camden, New Jersey, 08103
Northwestern University
Chicago, Illinois, 60611
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida Health Shands Hospital
Gainesville, Florida, 32610
Stern Cardiovascular Foundation
Germantown, Tennessee, 38138
Cone Health
Greensboro, North Carolina, 27401
Huntington Hospital
Huntington, New York, 11743
Jackson Heart Clinic
Jackson, Mississippi, 39216
University of Kansas Medical Center
Kansas City, Kansas, 66160
Norton Heart Specialists
Louisville, Kentucky, 40241
NYU Langone Hospital Long Island
Mineola, New York, 11501
Saint Joseph Heritage Hospital
Mission Viejo, California, 92691
Oklahoma Heart Hospital Research Foundation
Oklahoma City, Oklahoma, 73120
HCA Healthcare
Overland Park, Kansas, 66211
Desert Heart Rhythm Consultants
Palm Springs, California, 92262
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Valley Hospital
Ridgewood, New Jersey, 07450-2726
Stormont Vail Health Cotton O'Neil Clinical Research Center
Topeka, Kansas, 66606
White Plains Hospital Medical Center
White Plains, New York, 10601
About this study
Official title: 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.
Read the detailed description
The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the market- released LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. The Medtronic Discovery app will be used to collect data both (1) via the iPhone® through patient-reported health surveys and Bluetooth-enabled devices connected through the Apple Health app and (2) data accessed through or stored on the phone pertaining to health records, activity, and other lifestyle data. Secondarily, this study will examine associations between clinical procedures, medications and lifestyle actions taken and their impact on device-detected AF. Additionally, this study will help Medtronic evaluate patients' interaction with reports generated from health data collected by the market-released LINQ ICM. This study will improve our understanding of how data from the LINQ family of devices can be used to guide the management of AF patients.
- Conditions
- Atrial Fibrillation
- Being tested
- Non-Interventional
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
Non-Interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare Utilization Where AF Was a Reason or a Suspected Reason for the Healthcare Interaction.
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.
A predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC.
Measured: Through study completion (2 years of enrollment, up to 2.6 years of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start21 Jun 2021
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Piccini, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926857
- Sponsor's protocol ID
- MDT20024
- Acronym
- DEFINE AFib
- Status last verified
- Jul 2025
- First submitted
- 4 Jan 2021
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEFINE AFib Atrial Fibrillation - Development of a Predictive Model for Future Health Care Utilization From Measurements Collected From an Implantable Cardiac Monitor.
- ClinicalTrials.gov ID
- NCT04926857
- Acronym / sponsor ID
- DEFINE AFib / MDT20024
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to evaluate the association between complex patterns of device-detected AF and other summary and episodic measurements collected by the market- released LINQ ICM device and AF-related healthcare utilization, quality of life, AF-related symptoms, and specific clinical outcomes in patients with a market-released LINQ ICM. The Medtronic Discovery app will be used to collect data both (1) via the iPhone® through patient-reported health surveys and Bluetooth-enabled devices connected through the Apple Health app and (2) data accessed through or stored on the phone pertaining to health records, activity, and other lifestyle data. Secondarily, this study will examine associations between clinical procedures, medications and lifestyle actions taken and their impact on device-detected AF. Additionally, this study will help Medtronic evaluate patients' interaction with reports generated from health data collected by the market-released LINQ ICM. This study will improve our understanding of how data from the LINQ family of devices can be used to guide the management of AF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Atrial Fibrillation and a LINQ device
Key inclusion criteria (11 listed)
- 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:
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNon-Interventional | Other | – |
Primary outcome
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)
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. A predictive model was trained on 70% of the patients with adequate data available and assessed in a validation data set of the remaining 30% of patients, using rolling 60 day blocks. In each block, measurements in the first 30 days were used to predict whether confirmed HCU occurred in the trailing 30 days. Predictive value was assessed using sensitivity, specificity and other measurements within a confusion matrix as well as an area under the receiver operator curve, balancing the sensitivity and specificity. Outcome measure entered here will be AUROC.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Piccini, MD principal investigator
Duke University
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Medtronic Cardiac Rhythm and Heart Failure at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.