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New imaging strategy after heart valve procedure shows promise in pilot study

NCT ID NCT02797158

Knowledge-focused Sponsor: University Hospital, Montpellier 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a strategy to decide which patients need additional artery-opening treatment after a TAVI heart valve procedure. Researchers used a special imaging scan (SPECT) to look for areas of the heart not getting enough blood. The goal was to see if this imaging-guided approach could safely guide treatment decisions in 71 patients with severe aortic stenosis and stable coronary artery disease.

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

71 people

The number who actually took part.

Started

Jun 2016

Finished

Jul 2019

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: * Patients older than 18 years * Severe and symptomatic aortic stenosis defined as a median trans-valvular gradient higher than 40 mmHg and an aortic valve area of less than 1.0 cm2 or 0,6 cm2/m2 on echocardiography associated to significant CAD defined by ≥1 stenosis of ≥70% in a major epicardial coronary artery or ≥50% for left main * Patients is not candidate for surgical aortic valve replacement after the multidisciplinary heart team decision. Exclusion Criteria: * Recent acute coronary syndrome (within 30 days before randomization), * Unprotected left main disease * Critical stenosis (\>90%) of Left Anterior Descending artery (LAD), * Significant angina (CCS class more than 2) * Active bleeding, * Contraindication for tomographic technetium-99 assessment or dipyridamole injection * Previous enrollment in a other study * Impossibly to obtain consent

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis coronary artery disorder myocardial ischemia

As listed by the trial registrant

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

Severe and symptomatic aortic stenosis Stable coronary disease

Contacts and locations

Locations

  • Montpellier University Hospital

    Montpellier, 34295, France

More trials for these conditions

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