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Smartwatch data could decide when to fix a leaky heart valve

NCT ID NCT07690748

Knowledge-focused Sponsor: Baker Heart and Diabetes Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests whether wearable devices and artificial intelligence can help personalize the timing of valve replacement in people with moderate to severe aortic stenosis who have no symptoms. Participants wear a smartwatch to track heart rate, activity, and blood pressure, and undergo advanced heart imaging and blood tests. The goal is to build a 'digital twin' that predicts when valve intervention is needed, avoiding unnecessary surgery while preventing heart damage.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors determine the best time for valve replacement in people with aortic stenosis, potentially improving outcomes and avoiding unnecessary procedures.
What could go wrong
This is an observational study, not a treatment trial. The digital twin model is experimental and may not accurately predict individual outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.