RecruitingPhase 3NCT05836987

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Sponsor

Johns Hopkins University

Enrollment

5,350 participants

Start Date

Jul 13, 2023

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.

Eligibility

Min Age: 22 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether using a smartwatch to continuously monitor for irregular heart rhythms can help doctors reduce blood thinning medication in people with atrial fibrillation who have a lower stroke risk. **You may be eligible if...** - You are between 22 and 85 years old - You speak English - You have a history of non-permanent atrial fibrillation - Your stroke risk score (CHA2DS2-VASc) is in a specific moderate range - You are currently taking a blood thinner (DOAC) and are willing to continue - You own a compatible iPhone with a cellular plan and are willing to wear a smartwatch at least 14 hours a day **You may NOT be eligible if...** - You have had a prior stroke or TIA - You fall outside the required stroke risk score range - You are unable or unwilling to use the required technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAFSW Guided DOAC

The AFSW will intermittently and passively assess for rhythm irregularities consistent with AF and notify the wearer and coordinating center if a threshold AF event has occurred.

DRUGContinuous DOAC therapy

DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.

Locations(93)

Banner University

Phoenix, Arizona, United States

University of Southern California - Keck School of Medicine

Los Angeles, California, United States

University of California Los Angeles (UCLA Health)

Los Angeles, California, United States

UC Davis Health

Sacramento, California, United States

Scripps Health

San Diego, California, United States

Kaiser Permanente

San Francisco, California, United States

Stanford University

Stanford, California, United States

University of Colorado

Aurora, Colorado, United States

South Denver Cardiology Associates, P.C.

Littleton, Colorado, United States

St. Elizabeth's Medical Center

Washington D.C., District of Columbia, United States

Medical Faculty Associates George Washington University

Washington D.C., District of Columbia, United States

BayCare Health Systems

Clearwater, Florida, United States

University of Florida

Gainesville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Miami - Leonard S. Miller SOM

Miami, Florida, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Cleveland Clinic Florida

Stuart, Florida, United States

Baycare Health Systems Clearwater

Winter Haven, Florida, United States

Emory University

Atlanta, Georgia, United States

Georgia Arrhythmia Consultants and Research Institute

Warner Robins, Georgia, United States

University of Illinois Chicago

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Loyola University Chicago

Chicago, Illinois, United States

Alexian Brothers Health System

Elk Grove Village, Illinois, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Ascension St. Vincent

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Maine Medical Partners MaineHealth Cardiology

Scarborough, Maine, United States

Johns Hopkins Univeristy

Baltimore, Maryland, United States

Tufts Medical Center