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NCT Number: NCT07690748

Remote Monitoring for Patients With Aortic Stenosis

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age
  • Suitable to undergo MRI scans
  • With asymptomatic moderate to severe native AS (based on guideline-recommended diagnosis and care)
  • Eligible for Medicare
  • Ability and willingness to provide written and informed consent and to comply with the requirements of the study.

Exclusion criteria

  • Serious comorbidity other than AS that limits the life expectancy (<2 years), or affects study participation or outcome (severe frailty and mobility issues [Rockwood frailty score >6], severe kidney disease eGFR<30, infiltrative cardiomyopathy)
  • Known heart failure or reduced left ventricular ejection fraction (<50%)
  • Moderate or above valvular pathology other than AS
  • Contra-indications to CMR (including presence of foreign metallic bodies)
  • Known hypersensitivity to adenosine (ever requiring hospital admission with asthma or chronic obstructive pulmonary disease) or gadolinium
  • Significant renal impairment (eGFR<30ml/min/m2)

Treatment and study plan

Primary outcomes

  1. LV hypertrophy

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Left ventricular mass index[g/m2], imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  2. Diastolic function - Mitral inflow E/A ratio

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Mitral inflow E/A ratio, imaging endpoint on echocardiography

  3. Diastolic function - average E/e' ratio

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Average E/e' ratio, imaging endpoint on echocardiography

  4. Diastolic function - septal e' velocity

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Septal e' velocity, imaging endpoint on echocardiography.

  5. Diastolic function - lateral e' velocity

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Lateral e' velocity, imaging endpoint on echocardiography.

  6. Diastolic function - left atrial volume index

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Left atrial volume index, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  7. Diastolic function - peak diastolic strain rate

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Peak diastolic strain rate, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  8. Global longitudinal strain (GLS)

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  9. Myocardial perfusion

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Rest and adenosine stress CMR-measured myocardial blood flow and myocardial perfusion reserve imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  10. Myocardial energetics index

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    31P-MRS-measured phosphocreatine to ATP ratio, imaging endpoint on cardiovascular magnetic resonance spectroscopy (MRS)

  11. Myocardial triglyceride content

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Imaging endpoint as measured by 1H-MRS

  12. Myocardial fibrosis index - extra cellular volume [ECV] fraction

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Extra cellular volume [ECV] fraction, tissue characteristic imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  13. Myocardial fibrosis index - index-ECV

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Index-ECV, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

  14. Myocardial fibrosis index - scar percentage

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Late gadolinium enhancement imaging-assessed scar percentage, imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

Secondary outcomes

  1. Physical activity

    Time frame: Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

    Digital endpoint measured from wearable devices and processed via the SMART architecture

  2. Blood pressure

    Time frame: Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

    Digital endpoint measured from wearable devices and processed via the SMART architecture

  3. Heart rhythm

    Time frame: Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

    Digital endpoint measured from wearable devices and processed via the SMART architecture

  4. Heart rate variability

    Time frame: Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

    Digital endpoint measured from wearable devices and processed via the SMART architecture

  5. Oxygen saturation

    Time frame: Daily for the duration of the participant's participation in the study (six months post guideline-indicated AVR, or if AVR is not performed until completion of the overall study, i.e. maximum 4 years, whichever comes first).

    Digital endpoint measured from wearable devices and processed via the SMART architecture

  6. NTproBNP

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Blood biomarker

  7. High sensitivity cardiac troponin (hscTNT)

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Blood biomarker

  8. Proteomics

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Advanced, label-free quantitative mass spectrometry-based proteomics blood biomarkers

  9. Quality-of-Life questionnaire: KCCQ-CSS

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Patient-reported outcome measure via Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score [KCCQ-CSS]

  10. Quality-of-Life questionnaire: EQ-5D-5L

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Patient-reported outcome measure via EuroQoL 5-dimension 5-level [EQ-5D-5L] index score

  11. Quality-of-Life questionnaire: Toronto AS QoL

    Time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR

    Patient-reported outcome measure via "Toronto Aortic Stenosis" quality of life questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Sjoerd Levelt, PhD

CONTACT

[email protected]

+61385321874

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Collaborators

  • Deakin University
  • La Trobe University
  • Melbourne Health
  • Monash Medical Centre
  • St Vincent's Hospital Melbourne
  • The Alfred
  • The University of Western Australia
  • University of Melbourne

Registry information

Official study title

Remote Monitoring for Asymptomatic Patients With Moderate to Severe Aortic Valve Stenosis - Remote-AS

Acronym: Remote-AS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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