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NCT05836987PHASE3Recruiting

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Johns Hopkins University

Start Date

7/13/2023

Completion Date

7/31/2029

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.

Detailed Description

REACT-AF is a prospective, unblinded, randomized (1:1 allocation), multi-center, investigational clinical trial of men and women aged 22-85 with a documented history of symptomatic or asymptomatic paroxysmal or persistent (AF) and a moderate risk of stroke measured by CHA2DS2-VASc score 1-4 for men, 2-4 for women (which stands for Congestive heart failure, Hypertension, Age ≥75 (doubled), Diabetes, Stroke (doubled), Vascular disease, age 65 to 74 and sex category (female)). Participants randomized to the experimental arm (on demand DOAC) will take the participants DOAC for 30 consecutive days following a qualifying AF episode (i.e., greater than1 hour) detected by the AFSW. Participants randomized to the standard of care (control) arm will remain on previously prescribed continuous DOAC throughout the study. A total of 5350 participants will be enrolled across up to 100 study sites targeting two-thirds academic and one-third private practices, with academic practices also enrolling from affiliated community sites. The investigators anticipate evaluating 7643 consented individuals with external monitoring to ensure that a low AF burden population will be randomized. Up to 200 participants may be enrolled at any one site, and participation will last up to 60 months.

Eligibility Criteria

Age Range: 22 years to 85 years

Inclusion Criteria: 1. 22-85 years of age. 2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated. 3. History of non-permanent atrial fibrillation. 4. CHA2DS2-VASC score of 1-4 for men and 2-4 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \< 40%. 5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study. 6. Willing and able to comply with the protocol, including: * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan * Be willing to wear the smart watch for the suggested minimum of 14 hours a day * Expected to be within cellular service range at least 80% of the time 7. Willing and able to discontinue DOAC 8. The participant is willing and able to provide informed consent. Exclusion Criteria: 1. Valvular or permanent atrial fibrillation. 2. Current treatment with warfarin and unwilling or unable to take a DOAC. 3. The participant is a woman who is pregnant or nursing. 4. The participant is being treated with chronic aspirin, another anti-platelet agent, or chronic NSAIDS outside of current medical guidelines (e.g., primary stroke prevention in patients with atrial fibrillation, primary prevention of cardiovascular events, pain relief, fever, gout) and is unwilling or unable to discontinue use for the study duration. 5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment. 6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months. 7. Any documented single AF episode lasting ≥ 1 hour on standard of care or study-provided external cardiac monitor of \> 6 days duration performed within 45 days prior to randomization. Shorter monitoring durations may be acceptable for inclusion at the discretion of the site PI based on the totality of monitoring data and approval of the study PI. 8. Ablation for AF within the last 2 months. 9. Prior or anticipated left atrial appendage occlusion or ligation. 10. Mechanical prosthetic valve(s) or severe valve disease. 11. Hypertrophic cardiomyopathy. 12. Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve). 13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion. 14. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial. 15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn. 16. The participant has a tremor on their ipsilateral side that the AFSW may be worn. 17. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse). 18. Known hypersensitivity or contraindication to direct oral anticoagulants. 19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack. 20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF. 21. \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring. 22. History of atrial flutter that has not been treated with ablation (participants in atrial flutter and have been ablated are eligible for enrollment). 23. Stage 4 or 5 chronic kidney disease. 24. Conditions associated with an increased risk of bleeding: * Major surgery in the previous month * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks. * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days * Hemorrhagic disorder or bleeding diathesis * Need for anticoagulant treatment for disorders other than AF * Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)

Interventions

DEVICE

AFSW Guided DOAC

DRUG

Continuous DOAC therapy

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Conditions

Atrial Fibrillation

Locations

Banner University

Phoenix, Arizona 85006

United States

University of Southern California - Keck School of Medicine

Los Angeles, California 90033

United States

University of California Los Angeles (UCLA Health)

Los Angeles, California 90095

United States

UC Davis Health

Sacramento, California 95817

United States

Scripps Health

San Diego, California 92103

United States

Kaiser Permanente

San Francisco, California 94115

United States

Stanford University

Stanford, California 94305

United States

University of Colorado

Aurora, Colorado 80045

United States

South Denver Cardiology Associates, P.C.

Littleton, Colorado 80120

United States

St. Elizabeth's Medical Center

Washington D.C., District of Columbia 20032

United States

Medical Faculty Associates George Washington University

Washington D.C., District of Columbia 20037

United States

BayCare Health Systems

Clearwater, Florida 33759

United States

University of Florida

Gainesville, Florida 32611

United States

Mayo Clinic

Jacksonville, Florida 32224

United States

University of Miami - Leonard S. Miller SOM

Miami, Florida 33136

United States

Sarasota Memorial Health Care System

Sarasota, Florida 34236

United States

Cleveland Clinic Florida

Stuart, Florida 34994

United States

Baycare Health Systems Clearwater

Winter Haven, Florida 33881

United States

Emory University

Atlanta, Georgia 30332

United States

Georgia Arrhythmia Consultants and Research Institute

Warner Robins, Georgia 31093

United States

University of Illinois Chicago

Chicago, Illinois 60607

United States

Northwestern University

Chicago, Illinois 60611

United States

Rush University Medical Center

Chicago, Illinois 60612

United States

University of Chicago

Chicago, Illinois 60637

United States

Loyola University Chicago

Chicago, Illinois 60660

United States

Alexian Brothers Health System

Elk Grove Village, Illinois 60007

United States

NorthShore University HealthSystem

Evanston, Illinois 60201

United States

Midwest Cardiovascular Institute

Naperville, Illinois 60540

United States

Ascension St. Vincent

Indianapolis, Indiana 46260

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

Maine Medical Partners MaineHealth Cardiology

Scarborough, Maine 04074

United States

Johns Hopkins Univeristy

Baltimore, Maryland 21218

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Mass General Hospital

Boston, Massachusetts 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts 02115

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

BMC - Brighton

Boston, Massachusetts 02135

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Lahey Hospital & Medical Center

Burlington, Massachusetts 01805

United States

UMass Chan Medical School

Worcester, Massachusetts 01655

United States

Henry Ford Health

Detroit, Michigan 48202

United States

Corewell Health (Former Spectrum Health)

Grand Rapids, Michigan 49503

United States

Trinity Health Grand Rapids/Mercy Health

Grand Rapids, Michigan 49503

United States

William Beaumont Hospital

Royal Oak, Michigan 48073

United States

Trinity Health Michigan Heart - Ann Arbor

Ypsilanti, Michigan 48197

United States

Essentia Health The Duluth Clinic

Duluth, Minnesota 55812

United States

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota 55407

United States

Hennepin Healthcare Research Institute

Minneapolis, Minnesota 55415

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

University Health Truman Medical Center

Kansas City, Missouri 64108

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Advanced Heart and Vascular Institute of Hunterdon

Flemington, New Jersey 08822

United States

Hackensack Meridian Health

Hackensack, New Jersey 07601

United States

Rutgers, the State University of New Jersey

Piscataway, New Jersey 08854

United States

The Valley Hospital, Inc.

Ridgewood, New Jersey 07450

United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico 87102

United States

Presbyterian Healthcare Services

Albuquerque, New Mexico 87106

United States

University at Buffalo

Buffalo, New York 14214

United States

NYU Langone Health

New York, New York 10016

United States

Columbia University Medical Center

New York, New York 10032

United States

Weill Medical College of Cornell University

New York, New York 10065

United States

NewYork Presbyterian - Queens

Queens, New York 11355

United States

Staten Island University Hospital-Northwell Health

Staten Island, New York 10305

United States

Stony Brook University

Stony Brook, New York 11794

United States

Westchester Medical Center

Valhalla, New York 10595

United States

White Plains Hospital

White Plains, New York 10601

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

Wake Forest Baptist Health

Winston-Salem, North Carolina 27157

United States

The Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio 45219

United States

University of Cincinnati College of Medicine

Cincinnati, Ohio 45267

United States

Ohio State University Medical Center

Columbus, Ohio 43210

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Wooster Community Hospital

Wooster, Ohio 44691

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73104

United States

Cardiology Consultants of Philadelphia

Paoli, Pennsylvania 19301

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19144

United States

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania 15212

United States

Penn State Health Medical Group Berks Cardiology

Wyomissing, Pennsylvania 19610

United States

Rhode Island Hospital

Providence, Rhode Island 02903

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

MUSC Health Heart and Vascular

Columbia, South Carolina 29204

United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas 78705

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84112

United States

University of Virginia

Charlottesville, Virginia 22903

United States

James River Cardiology

Richmond, Virginia 23229

United States

Virginia Commonwealth University

Richmond, Virginia 23284

United States

St. Joseph Medical Center Tacoma

Tacoma, Washington 98405

United States

University of Wisconsin

Madison, Wisconsin 53706

United States

Medical College of Wisconsin Froedtert Hospital

Milwaukee, Wisconsin 53226

United States