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Heart valve surgery before symptoms? new study tests if early action saves lives

NCT ID NCT03094143

Disease control Sponsor: University of Edinburgh 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study looks at people with severe aortic stenosis (a narrowed heart valve) who don't yet have symptoms. Doctors usually wait until symptoms appear before replacing the valve, but by then the heart may already be damaged. The researchers use MRI scans to find hidden scarring in the heart muscle. If scarring is found, patients are randomly assigned to either standard care or early valve replacement (surgery or TAVI). The goal is to see if early surgery reduces deaths and hospital stays.

What this could mean

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

Active substance
Aortic valve replacement (surgery or TAVI)
What this could lead to
If successful, this could show that replacing the valve earlier, before symptoms appear, saves lives and prevents heart damage.
What could go wrong
This is a large but still early-stage study. The MRI scarring method may not reliably predict who benefits, and surgery itself carries risks like infection or stroke.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

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

Started

Jul 2017

Expected to finish

Jun 2032

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.

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: 1. Severe aortic stenosis (aortic valve jet velocity ≥4.0 m/s, or aortic valve area indexed to body surface area \<0.6cm2/m2 with aortic jet velocity ≥3.5m/s) 2. Age over 18 years 3. No symptoms attributable to aortic stenosis that require aortic valve replacement Exclusion Criteria: 1. Deemed lower risk for mid-wall fibrosis on screening 2. Planned cardiac surgery 3. Previous valve replacement 4. Severe hypertension (systolic \>180 or diastolic \>110 mmHg) 5. Acute pulmonary oedema or cardiogenic shock 6. Left ventricular ejection fraction \<50% on cardiac MRI 7. Significant abnormalities on cardiac MRI that would prevent enrolment 8. Coexistent severe aortic regurgitation or mitral regurgitation 9. Coexistent mitral stenosis greater than mild in severity 10. Coexistent hypertrophic cardiomyopathy or cardiac amyloidosis 11. Any contraindication to MRI scanning (such as permanent pacemaker) 12. Advanced renal impairment (glomerular filtration rate \<30 mL/min/1.73 m2) 13. Pregnancy or breast feeding 14. Patient judged to be unfit to be considered for aortic valve replacement or transcatheter aortic valve implantation 15. Patient declines to consider undergoing valve replacement surgery or transcatheter aortic valve implantation 16. Inability to give informed consent 17. Previous randomisation into this study

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Hypertrophy, Left Ventricular

As listed by the trial registrant

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

Aortic valve stenosis Hypertrophy, left ventricular

Contacts and locations

Locations

  • NHS Lothian

    Edinburgh, United Kingdom

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