DEFINE AFib (Atrial Fibrillation)

NCT04926857 | Terminated Results

• 1 other identifier: MDT20024
• Study Type: observational
• Target: 973
• Locations: 1 country
• Sites: 26

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion (2 years of enrollment, up to 2.6 years of follow-up)

Interventions

Non-Interventional OTHER

Non-Interventional

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Atrial Fibrillation and a LINQ device

You may qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (26)

Saint Joseph Heritage Hospital

Mission Viejo, California, 92691, United States

Location

Desert Heart Rhythm Consultants

Palm Springs, California, 92262, United States

Location

Florida Electrophysiology Associates

Atlantis, Florida, 33462-6614, United States

Location

Cardiac Arrhythmia Service

Boca Raton, Florida, 33432, United States

Location

University of Florida Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

HCA Healthcare

Overland Park, Kansas, 66211, United States

Location

Stormont Vail Health Cotton O'Neil Clinical Research Center

Topeka, Kansas, 66606, United States

Location

Norton Heart Specialists

Louisville, Kentucky, 40241, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450-2726, United States

Location

New York Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Huntington Hospital

Huntington, New York, 11743, United States

Location

NYU Langone Hospital Long Island

Mineola, New York, 11501, United States

Location

White Plains Hospital Medical Center

White Plains, New York, 10601, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cone Health

Greensboro, North Carolina, 27401, United States

Location

Oklahoma Heart Hospital Research Foundation

Oklahoma City, Oklahoma, 73120, United States

Location

St. Luke's Cardiology Associates

Bethlehem, Pennsylvania, 18018, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Ascension Seton Heart Institute Clinical Research

Austin, Texas, 78705, United States

Location

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nirav Patel
• Organization: Medtronic

nirav.a.patel@medtronic.com

1 (800) 633-8766

Study Officials

• Jonathan Piccini, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: June 15, 2021
• Study Start: June 21, 2021
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Locations

US (26)