The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation

Conditions

• Atrial Fibrillation

Eligibility Criteria

Sex

ALL

Age

22 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• AFSW Guided DOAC — DEVICE
  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.
• Continuous DOAC therapy — DRUG
  DOACs will be prescribed to patients according to the treating healthcare provider(s) according to labeling instructions.

Study Details

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.

Key Dates

Start date

Jul 13, 2023

Status verified

Apr 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

5,350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: AFSW Guided DOAC
  All participants randomized to the experimental arm will be provided with an AFSW that will be linked to the participants Apple watch and the secure REACT-AF app within the Eureka cloud. 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.
• Active Comparator: Continuous DOAC therapy
  All participants randomized to the control arm will remain on previously prescribed FDA-approved DOAC regimen as indicated by current practice standards. These participants will continuously take DOAC through the course of the study as prescribed by the participants primary physician unless otherwise contraindicated. Participants in the control arm will also use the REACT-AF mobile app within the Eureka platform via Apple watch for study follow-up activities, but the participants will not receive an AFSW and any personally owned Apple Watch will not be loaded with the customized REACT-AF detection algorithm nor participant notification apps.

Primary Outcome Measure

To assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality. [ Time Frame: At 60 months ]

Central Contacts

• Shea Smith
  650-724-6211
  [email protected]

Locations (93)

Find similar trials in Phoenix, AZ

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