Actively Recruiting

Phase 3
Age: 22Years - 85Years
All Genders
NCT05836987

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Led by Johns Hopkins University · Updated on 2026-04-09

5350

Participants Needed

93

Research Sites

315 weeks

Total Duration

On this page

Sponsors

J

Johns Hopkins University

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Who Can Participate

Age: 22Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 22 and 85 years
  • English-speaking participants (Spanish-only speakers may be included in future at select sites)
  • History of non-permanent (paroxysmal or persistent) atrial fibrillation
  • CHA2DS2-VASc score 1-4 for men and 2-4 for women without prior stroke or transient ischemic attack
  • Currently taking a direct oral anticoagulant (DOAC) and willing to continue for the study duration
  • Able to comply with the protocol including owning a compatible smartphone, willingness to wear the smartwatch at least 14 hours daily, and being within cellular service range most of the time
  • Willing and able to discontinue DOAC as needed
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Permanent or valvular atrial fibrillation
  • Current treatment with warfarin and unable or unwilling to take DOAC
  • Pregnant or nursing women
  • Chronic use of aspirin, other antiplatelet agents, or NSAIDs outside guidelines and unwilling or unable to stop during study
  • Existing cardiac rhythm device or need for pacemaker, defibrillator, or cardiac resynchronization device or planned insertable monitor used to guide anticoagulation
  • Known or suspected AF lasting 1 hour or more per month over past 3 months
  • Recent AF episodes lasting 1 hour or more on monitoring within 45 days before randomization
  • AF ablation within last 2 months
  • Prior or planned left atrial appendage occlusion or ligation
  • Mechanical heart valve or severe valve disease
  • Hypertrophic cardiomyopathy
  • Need for DOAC for reasons other than AF-related stroke prevention
  • High risk for non-cardioembolic stroke (e.g., severe carotid artery disease)
  • Participation in another drug or device study within 30 days or planned during this trial without approval
  • Tattoos, birthmarks, or scars on the wrist where the smartwatch would be worn
  • Tremor on the wrist side where the smartwatch would be worn
  • Any condition deemed unsafe for study participation by the investigator
  • Known allergy or contraindication to DOACs
  • Prior stroke or transient ischemic attack
  • Reversible AF causes like cardiac surgery or untreated hyperthyroidism
  • More than 5% premature atrial or ventricular beats on monitoring before enrollment
  • Untreated atrial flutter
  • Stage 4 or 5 chronic kidney disease
  • Conditions increasing bleeding risk such as recent major surgery, planned surgery needing anticoagulation stop, history of serious bleeding, recent ulcers, bleeding disorders, uncontrolled high blood pressure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 93 locations

1

Banner University

Phoenix, Arizona, United States, 85006

Actively Recruiting

2

University of Southern California - Keck School of Medicine

Los Angeles, California, United States, 90033

Actively Recruiting

3

University of California Los Angeles (UCLA Health)

Los Angeles, California, United States, 90095

Actively Recruiting

4

UC Davis Health

Sacramento, California, United States, 95817

Actively Recruiting

5

Scripps Health

San Diego, California, United States, 92103

Actively Recruiting

6

Kaiser Permanente

San Francisco, California, United States, 94115

Not Yet Recruiting

7

Stanford University

Stanford, California, United States, 94305

Actively Recruiting

8

University of Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

9

South Denver Cardiology Associates, P.C.

Littleton, Colorado, United States, 80120

Actively Recruiting

10

St. Elizabeth's Medical Center

Washington D.C., District of Columbia, United States, 20032

Actively Recruiting

11

Medical Faculty Associates George Washington University

Washington D.C., District of Columbia, United States, 20037

Withdrawn

12

BayCare Health Systems

Clearwater, Florida, United States, 33759

Actively Recruiting

13

University of Florida

Gainesville, Florida, United States, 32611

Actively Recruiting

14

Mayo Clinic

Jacksonville, Florida, United States, 32224

Actively Recruiting

15

University of Miami - Leonard S. Miller SOM

Miami, Florida, United States, 33136

Actively Recruiting

16

Sarasota Memorial Health Care System

Sarasota, Florida, United States, 34236

Actively Recruiting

17

Cleveland Clinic Florida

Stuart, Florida, United States, 34994

Withdrawn

18

Baycare Health Systems Clearwater

Winter Haven, Florida, United States, 33881

Actively Recruiting

19

Emory University

Atlanta, Georgia, United States, 30332

Actively Recruiting

20

Georgia Arrhythmia Consultants and Research Institute

Warner Robins, Georgia, United States, 31093

Actively Recruiting

21

University of Illinois Chicago

Chicago, Illinois, United States, 60607

Actively Recruiting

22

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

23

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

24

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

25

Loyola University Chicago

Chicago, Illinois, United States, 60660

Actively Recruiting

26

Alexian Brothers Health System

Elk Grove Village, Illinois, United States, 60007

Actively Recruiting

27

NorthShore University HealthSystem

Evanston, Illinois, United States, 60201

Actively Recruiting

28

Midwest Cardiovascular Institute

Naperville, Illinois, United States, 60540

Actively Recruiting

29

Ascension St. Vincent

Indianapolis, Indiana, United States, 46260

Actively Recruiting

30

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

31

Maine Medical Partners MaineHealth Cardiology

Scarborough, Maine, United States, 04074

Actively Recruiting

32

Johns Hopkins Univeristy

Baltimore, Maryland, United States, 21218

Actively Recruiting

33

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

34

Mass General Hospital

Boston, Massachusetts, United States, 02114

Not Yet Recruiting

35

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

36

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

37

BMC - Brighton

Boston, Massachusetts, United States, 02135

Actively Recruiting

38

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

39

Lahey Hospital & Medical Center

Burlington, Massachusetts, United States, 01805

Actively Recruiting

40

UMass Chan Medical School

Worcester, Massachusetts, United States, 01655

Active, Not Recruiting

41

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

42

Corewell Health (Former Spectrum Health)

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

43

Trinity Health Grand Rapids/Mercy Health

Grand Rapids, Michigan, United States, 49503

Actively Recruiting

44

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

Actively Recruiting

45

Trinity Health Michigan Heart - Ann Arbor

Ypsilanti, Michigan, United States, 48197

Actively Recruiting

46

Essentia Health The Duluth Clinic

Duluth, Minnesota, United States, 55812

Active, Not Recruiting

47

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

48

Hennepin Healthcare Research Institute

Minneapolis, Minnesota, United States, 55415

Actively Recruiting

49

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

50

University Health Truman Medical Center

Kansas City, Missouri, United States, 64108

Withdrawn

51

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

52

Advanced Heart and Vascular Institute of Hunterdon

Flemington, New Jersey, United States, 08822

Actively Recruiting

53

Hackensack Meridian Health

Hackensack, New Jersey, United States, 07601

Actively Recruiting

54

Rutgers, the State University of New Jersey

Piscataway, New Jersey, United States, 08854

Actively Recruiting

55

The Valley Hospital, Inc.

Ridgewood, New Jersey, United States, 07450

Actively Recruiting

56

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States, 87102

Actively Recruiting

57

Presbyterian Healthcare Services

Albuquerque, New Mexico, United States, 87106

Active, Not Recruiting

58

University at Buffalo

Buffalo, New York, United States, 14214

Actively Recruiting

59

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

60

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

61

Weill Medical College of Cornell University

New York, New York, United States, 10065

Actively Recruiting

62

NewYork Presbyterian - Queens

Queens, New York, United States, 11355

Actively Recruiting

63

Staten Island University Hospital-Northwell Health

Staten Island, New York, United States, 10305

Actively Recruiting

64

Stony Brook University

Stony Brook, New York, United States, 11794

Actively Recruiting

65

Westchester Medical Center

Valhalla, New York, United States, 10595

Actively Recruiting

66

White Plains Hospital

White Plains, New York, United States, 10601

Actively Recruiting

67

University of North Carolina

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

68

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

69

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, United States, 45219

Actively Recruiting

70

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States, 45267

Actively Recruiting

71

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

72

OhioHealth Research Institute

Columbus, Ohio, United States, 43214

Actively Recruiting

73

Wooster Community Hospital

Wooster, Ohio, United States, 44691

Actively Recruiting

74

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

75

Cardiology Consultants of Philadelphia

Paoli, Pennsylvania, United States, 19301

Not Yet Recruiting

76

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19144

Actively Recruiting

77

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

78

Penn State Health Medical Group Berks Cardiology

Wyomissing, Pennsylvania, United States, 19610

Actively Recruiting

79

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

80

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

81

MUSC Health Heart and Vascular

Columbia, South Carolina, United States, 29204

Actively Recruiting

82

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States, 78705

Actively Recruiting

83

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

84

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

85

Houston Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

86

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

87

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

88

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

89

James River Cardiology

Richmond, Virginia, United States, 23229

Actively Recruiting

90

Virginia Commonwealth University

Richmond, Virginia, United States, 23284

Actively Recruiting

91

St. Joseph Medical Center Tacoma

Tacoma, Washington, United States, 98405

Actively Recruiting

92

University of Wisconsin

Madison, Wisconsin, United States, 53706

Actively Recruiting

93

Medical College of Wisconsin Froedtert Hospital

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

S

Shea Smith

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation | DecenTrialz