DEFINE AFib (Atrial Fibrillation)

Atrial Fibrillation Clinical Trial

— DEFINE AFib  

Official title:

DEFINE AFib Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04926857
• Other study ID #: MDT20024
• Status: Completed
• Start date: June 21, 2021
• Est. completion date: January 25, 2024

Study information

• Verified date: April 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 973
• Est. completion date: January 25, 2024
• Est. primary completion date: January 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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:

• 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

Exclusion Criteria Patients with > 24 months elapsed time from recorded LINQ device implant or > 48 months elapsed from recorded LINQ II implant date

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Florida Electrophysiology Associates	Atlantis	Florida
United States	Ascension Seton Heart Institute Clinical Research	Austin	Texas
United States	PeaceHealth Saint Joseph Medical Center	Bellingham	Washington
United States	St. Luke's Cardiology Associates	Bethlehem	Pennsylvania
United States	Cardiac Arrhythmia Service	Boca Raton	Florida
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	New York Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Cooper University Hospital	Camden	New Jersey
United States	Northwestern University	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida Health Shands Hospital	Gainesville	Florida
United States	Stern Cardiovascular Foundation	Germantown	Tennessee
United States	Cone Health	Greensboro	North Carolina
United States	Huntington Hospital	Huntington	New York
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Norton Heart Specialists	Louisville	Kentucky
United States	NYU Langone Hospital Long Island	Mineola	New York
United States	Saint Joseph Heritage Hospital	Mission Viejo	California
United States	Oklahoma Heart Hospital Research Foundation	Oklahoma City	Oklahoma
United States	HCA Healthcare	Overland Park	Kansas
United States	Desert Heart Rhythm Consultants	Palm Springs	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Stormont Vail Health Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	White Plains Hospital Medical Center	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through study completion (2 years of enrollment, up to 5 years of follow-up)