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AMALFI: Active monitoring for atrial fibrillation

AMALFI (Active Monitoring for AtriaL Fibrillation): A randomized controlled trial of screening for silent atrial fibrillation in high-risk individuals.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15544176
Enrollment
5000
Registered
2019-05-21
Start date
2019-05-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System

Interventions

Eligible participants will be identified via an electronic search of GP practice data, identifying individuals with risk factors (such as diabetes or high blood pressure) that put them at an increased

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male or Female, aged > = 65 years old. 2. CHA2DS2-VASc score > = 3 in men or > = 4 in women. 3. Willing and able to give informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: 1. Known to have AF or atrial flutter 2. Latex allergy (given the potential for an allergic reaction to the Zio Patch)

Design outcomes

Primary

MeasureTime frame
To assess the effect of 2 weeks of continuous monitoring using Zio Patch on the proportion of participants diagnosed with AF compared to usual care at 2.5 years of follow up from randomization (i.e. at around the midpoint of a proposed 5-year screening interval).

Secondary

MeasureTime frame
Following the initial phase, all participants will continue with their normal care. At 1, 2½ and 5 years after randomization data will be collected from the GP records to assess the proportion of participants diagnosed with AF (as recorded in the electronic GP record) and to see if having AF diagnosed earlier, made a difference to their medical care and stroke rate.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026