APRAISE-AS

 Single centre, non-blinded, two-arm, parallel group, randomised controlled pilot trial of 66 patients with asymptomatic sAS.

The primary aim of this study is to pilot the trial protocol and assess the feasibility and potential refinement of the trial design prior to undertaking a larger randomised controlled trial investigating whether proactive reporting of symptoms, definitive disease specific patient reported outcome measures (PROMs) and assessment of frailty in addition to standard care can be used to help inform the timeliness of valve intervention in patients with asymptomatic severe aortic stenosis (sAS).

This study will be conducted in the Heart and Lung Centre at The Royal Wolverhampton NHS Trust which is a tertiary care centre for cardiothoracic surgery serving a population of 1.4 million in the Black Country and West Birmingham Integrated Care System.

The study will recruit adult patients with a confirmed diagnosis of asymptomatic sAS of a native valve. Patients will be identified for eligibility following a diagnosis of asymptomatic sAS and will be approached for recruitment prospectively from new referrals seen in out-patient clinics or following identification at ward level. Existing patients known to the Heart Team will also be approached for recruitment. A total number of 66 patients are to be recruited over a 12-month period.

Intervention arm: Standard care in addition to remote patient monitoring including app based: proactive symptom surveillance, health status and functional capacity. Control arm: Standard care (clinic-based observations “watchful waiting”)

• Assess the utility of the “app” using quantitative and qualitative data

• Adherence to intervention and reasons for non-adherence

• Recruitment rate per month

• Number of withdrawals and losses to follow-up (with reasons)

As part of the pilot study both patients and the clinical team will be asked to complete a questionnaire which will evaluate their satisfaction with regards to recruitment, the randomisation process, the extent and frequency of data collection, the frequency and duration of remote monitoring, the utility of the clinician’s portal and embedding remote monitoring into the clinical management pathway, the appropriateness of the alert thresholds and how these are flagged to the clinical team