Remote Monitoring for Patients With Aortic Stenosis

Summary

Remote-AS aims to develop a remote digital monitoring cohort of people with AS and use these data to establish a digital twin intervention to personalise risks and benefits, and optimise the time of surgical or transcatheter aortic valve replacement (AVR) referral. Our digital solution will also seek modelling for optimal care for patients to whom AVR is indicated who choose not to undergo the procedure, supporting a patient-selected observational strategy for managing heart failure symptoms, facilitating patient education and self-care.

Objectives of the study are:

* To establish a large-scale interdisciplinary research program to drive implementation of substantial improvements to health care and/or health system effectiveness in patients with aortic stenosis (AS)
* To establish a new model of patient-centred management strategy for asymptomatic severe AS to inform the optimal time at which valve intervention should take place
* For patients to whom AVR is indicated who choose not to undergo the procedure, to support a patient-selected observational strategy for managing heart failure symptoms
* To develop a digital twin with predictive capabilities of artificial intelligence (AI) for guiding the optimal timing of AVR in patients with asymptomatic severe AS

Participants will be patients with asymptomatic moderate to severe native AS (n=160) (based on guideline-recommended diagnosis and care with peak aortic velocity \>3.5m/sec).

Participants will undergo:

Wearables: collection of physiological (e.g., blood pressure, heart rate, rhythm) and behavioural (physical activity) data through a wearable device ('smart watch'), collected through the comprehensive remote heart health monitoring and automated feedback delivery system app SMART.

Patient reported outcome measures: KCCQ-CSS; EQ-5D-5L index score; "Toronto Aortic Stenosis" quality of life questionnaires.

Advanced cardiovascular imaging: Cardiovascular magnetic resonance (CMR) imaging; 31phosphorus magnetic resonance spectroscopy (31P-MRS); proton magnetic resonance spectroscopy (1H-MRS); echocardiography.

Comprehensive plasma proteome profiling: Plasma proteomic preparation coupled with the Orbitrap Astral mass spectrometer.

Recording of clinical outcomes.

Conditions

• Aortic Stenosis

Sponsors & Collaborators

• The Alfred

  collaborator OTHER

• Monash Medical Centre

  collaborator OTHER

• St Vincent's Hospital Melbourne

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Deakin University

  collaborator OTHER

• La Trobe University

  collaborator OTHER

• The University of Western Australia

  collaborator OTHER

• Melbourne Health

  collaborator OTHER

• Baker Heart and Diabetes Institute

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2030-08-31

Completion

2030-08-31