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The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

NCT05836987 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5350

Last updated 2026-04-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

AFSW 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.

DRUG

Continuous DOAC therapy

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

Sponsors & Collaborators

Principal Investigators

  • Rod Passman · Northwestern University

  • Dan Hanley · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-13
Primary Completion
2029-07-31
Completion
2029-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05836987 on ClinicalTrials.gov