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New decision aid aims to ease tough choices for rare heart defect

NCT ID NCT07544979

Knowledge-focused Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Updated 2 times

Summary

This study is creating a decision aid for people with a rare heart condition called right anomalous aortic origin of a coronary artery (R-AAOCA). The condition raises the risk of sudden cardiac death, but the best management—surgery or careful observation—isn't clear. The aid will help patients, families, and doctors weigh the options together. Researchers will test the tool in 60 participants aged 10-35 to see if it improves shared decision-making, comfort with the choice, and quality of life.

What this could mean

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

Active substance
decision aid
What this could lead to
If successful, this tool could help patients and families feel more confident and less anxious when choosing between surgery or monitoring for right AAOCA.
What could go wrong
This is a small pilot study (60 participants) testing a new tool, not a treatment. The aid may not improve decision-making or quality of life as hoped.

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 60 people

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

Started

Aug 2026

Expected to finish

Mar 2029

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

10 to 35 years

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 * English-speaking * 10-35 years of age * Diagnosis of R-AAOCA without evidence of myocardial ischemia Parents * English-speaking * Child 10-17 years of age * Diagnosis of R-AAOCA without evidence of myocardial ischemia Exclusion Criteria: * Patients * Other significant cardiac anomalies * Unwilling or unable to provide consent * Non-English Speaking Parents * Child with other significant cardiac anomalies * Unwilling or unable to provide consent * Non-English Speaking

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Conditions

The condition(s) this trial relates to.

coronary artery congenital malformation

As listed by the trial registrant

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

AAOCA

How to take part

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

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Boston Children's Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Dell Children's Medical Center

    NOT_YET_RECRUITING

    Austin, Texas, 78723, United States

  • Texas Children's Hospital

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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