AMALFI: Active Monitoring for AtriaL Fibrillation
Research type
Research Study
Full title
AMALFI (Active Monitoring for AtriaL Fibrillation): A randomized controlled trial of screening for silent atrial fibrillation in high-risk individuals.
IRAS ID
234837
Contact name
Louise Bowman
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
25 years, 0 months, 1 days
Research summary
AMALFI is a randomized trial of screening for undiagnosed atrial fibrillation (AF - a type of irregular heartbeat) in people thought to be at high risk of having the condition.
The trial aims to randomize 2500 participants in the UK, half of which will wear a CE-marked medical device called the Zio Patch. This is a self-applied ECG monitor that is worn for 2 weeks to assess for signs of AF even if the participant feels well. The intention is to assess the rate of undiagnosed AF to see if earlier detection (and therefore treatment) of undiagnosed AF is worthwhile and results in improved healthcare.
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 risk of having a stroke. Men and women aged 65 and over, with a high risk score, will be approached by mail by their GP and offered the opportunity to participate in the study.
If eligible and randomized to wear a patch, they will be sent the device and instructions on how to apply it. After wearing the device for two weeks, it will be returned for analysis and the results sent to their GP who may use the information to decide on the appropriate management. Those not randomized to wear a patch will continue on their usual care.
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.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/0220
Date of REC Opinion
30 Jan 2019
REC opinion
Favourable Opinion