Multi-centre open label randomised controlled trial of immediate enhanced ambulatory ECG monitoring versus standard monitoring in acute unexplained syncope patients
ASPIRED is an open prospective parallel group randomised controlled trial of a 14-day ambulatory heart ECG monitor (BodyGuardianMini; Preventice Solutions) applied to patients versus standard care monitoring in patients presenting acutely with unexplained syncope.
2234 adult (16 years or older) participants presenting acutely to UK hospitals with syncope remaining unexplained after initial assessment will be recruited in ~26 NHS acute tertiary and district hospitals. Participants will be randomised, 1:1, between the two study arms. Randomisation will be performed using a web-based randomisation service
The study will be conducted over 4 years. Recruitment will take place over 18 months commencing March 2022. All participants will be followed-up for 2 years after the index event.