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Aortic StenosisRemote-ASNCT07690748

Remote Monitoring for Patients With Aortic Stenosis

An observational study of Aortic Stenosis, run by Baker Heart and Diabetes Institute.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Stenosis
How many people
160 participants
Where
No sites listed yet
Study dates
1 Sep 2026to Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Potential participants will be identified by their cardiologist or cardiothoracic surgeon at high-volume Australian centres in Melbourne.

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Sjoerd Levelt, PhD contact

+61385321874

sjoerd.levelt@baker.edu.au

About this study

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

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:

Read more
  • 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
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07690748
Study groupRoleWhat they receive
Aortic stenosisPatients with asymptomatic moderate to severe native AS (n=160) (based on guideline-recommended diagnosis and care with peak aortic velocity >3.5m/sec).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LV hypertrophy

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

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

  2. Diastolic function - Mitral inflow E/A ratio

    Mitral inflow E/A ratio, imaging endpoint on echocardiography

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

  3. Diastolic function - average E/e' ratio

    Average E/e' ratio, imaging endpoint on echocardiography

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

  4. Diastolic function - septal e' velocity

    Septal e' velocity, imaging endpoint on echocardiography.

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

  5. Diastolic function - lateral e' velocity

    Lateral e' velocity, imaging endpoint on echocardiography.

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

  6. Diastolic function - left atrial volume index

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

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

  7. Diastolic function - peak diastolic strain rate

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

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

  8. Global longitudinal strain (GLS)

    Imaging endpoint on cardiovascular magnetic resonance imaging (CMR)

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

  9. Myocardial perfusion

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

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

  10. Myocardial energetics index

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

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

  11. Myocardial triglyceride content

    Imaging endpoint as measured by 1H-MRS

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

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

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

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

  13. Myocardial fibrosis index - index-ECV

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

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

  14. Myocardial fibrosis index - scar percentage

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

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

Secondary outcomes (11)
  1. Physical activity

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

    Measured: 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).

  2. Blood pressure

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

    Measured: 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).

  3. Heart rhythm

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

    Measured: 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).

  4. Heart rate variability

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

    Measured: 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).

  5. Oxygen saturation

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

    Measured: 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).

  6. NTproBNP

    Blood biomarker

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

  7. High sensitivity cardiac troponin (hscTNT)

    Blood biomarker

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

  8. Proteomics

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

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

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

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completionAug 2030 (estimated)
  4. Study completionAug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07690748
Sponsor's protocol ID
587-25
Other IDs
119917
Acronym
Remote-AS
Status last verified
Jul 2026
First submitted
22 Mar 2026
Last updated
8 Jul 2026
Results posted
No
Individual data sharing
Yes: Upon publications, the investigators envisage allowing access to the data in a systematic manner through a platform dedicated to sharing scientific research data (e.g., ShareFile). Specific datasets will be made available after publications by us and sharing of data is intended to be determined on a case-by-case basis at the discretion of the Principal Investigator, and provided agreement to preserve the confidentiality of the information. All data will be shared in a non-identifiable format. Data will be collected, stored and shared in accordance with National Statement 3.1.44 and 3.1.55. If journals request that the research team make raw data available, the anonymised raw non-identifiable data will be shared in a systematic manner through a platform dedicated to sharing scientific research data (e.g., ShareFile). The participant information/consent form includes this information for participants following guidelines from the Australian Research Data Commons (ARDC) guide.

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Stenosis, run by Baker Heart and Diabetes Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sjoerd Levelt, PhD (+61385321874, sjoerd.levelt@baker.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LV hypertrophy (time frame: 6-monthly repeat assessments prior to AVR, with a concluding assessment 6 months after AVR). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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