RECRUITING

The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

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Conditions

Atrial FibrillationAnticoagulationAF-sensing Smart WatchIschemic StrokeSystemic Embolism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-13
Study Completion:2029-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05836987

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 22-85 years of age.
  2. 2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
  3. 3. History of non-permanent atrial fibrillation.
  4. 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. 5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
  6. 6. Willing and able to comply with the protocol, including:
  7. * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan
  8. * Be willing to wear the smart watch for the suggested minimum of 14 hours a day
  9. * Expected to be within cellular service range at least 80% of the time
  10. 7. Willing and able to discontinue DOAC
  11. 8. The participant is willing and able to provide informed consent.
  1. 1. Valvular or permanent atrial fibrillation.
  2. 2. Current treatment with warfarin and unwilling or unable to take a DOAC.
  3. 3. The participant is a woman who is pregnant or nursing.
  4. 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. 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. 6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
  7. 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. 8. Ablation for AF within the last 2 months.
  9. 9. Prior or anticipated left atrial appendage occlusion or ligation.
  10. 10. Mechanical prosthetic valve(s) or severe valve disease.
  11. 11. Hypertrophic cardiomyopathy.
  12. 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. 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. 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. 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. 16. The participant has a tremor on their ipsilateral side that the AFSW may be worn.
  17. 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. 18. Known hypersensitivity or contraindication to direct oral anticoagulants.
  19. 19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
  20. 20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
  21. 21. \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.
  22. 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. 23. Stage 4 or 5 chronic kidney disease.
  24. 24. Conditions associated with an increased risk of bleeding:
  25. * Major surgery in the previous month
  26. * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks.
  27. * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding
  28. * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)
  29. * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
  30. * Hemorrhagic disorder or bleeding diathesis
  31. * Need for anticoagulant treatment for disorders other than AF
  32. * Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)

Contacts and Locations

Study Contact

Nicole Odenwald
CONTACT
650-725-3187
nicoleod@stanford.edu

Principal Investigator

Rod Passman
PRINCIPAL_INVESTIGATOR
Northwestern University
Dan Hanley
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

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
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, District of Columbia, 20032
United States
Medical Faculty Associates George Washington University
Washington, 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
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Boston Medical Center
Boston, Massachusetts, 02118
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
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
Saint Louis, Missouri, 63110
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
Wooster Community Hospital
Wooster, Ohio, 44691
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
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 Virginia
Charlottesville, Virginia, 22903
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

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Rod Passman, PRINCIPAL_INVESTIGATOR, Northwestern University
  • Dan Hanley, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-13
Study Completion Date2029-07-31

Study Record Updates

Study Start Date2023-07-13
Study Completion Date2029-07-31

Terms related to this study

Keywords Provided by Researchers

  • Atrial Fibrillation
  • Anticoagulation
  • AF-sensing Smart Watch
  • Ischemic Stroke
  • Systemic Embolism

Additional Relevant MeSH Terms

  • Atrial Fibrillation