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Heart defect study tracks kids' outcomes 11 years after surgery

NCT ID NCT02455531

Knowledge-focused Sponsor: Carelon Research 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 237 children born with hypoplastic left heart syndrome (HLHS), a serious heart defect. Researchers compare how well the heart works at age 11 in children who received one of two different shunts during their first surgery. The goal is to understand which shunt leads to better long-term heart function and survival.

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

237 people

The number who actually took part.

Start date

Jun 2015

Expected to finish

Dec 2025

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

All SVR study cohort members will be contacted to assess for vital status. Transplant free survivors will be approached to participate in the in-person assessment.

Ages

10 to 12 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: * All SVR study cohort members will be contacted to assess for vital status. Transplant free survivors will be approached to participate in the in-person assessment. Exclusion Criteria: * Patients who have undergone cardiac transplantation or biventricular conversion from all outcomes other than vital status. * Those with pacemakers will be excluded from the CMR, and patients \<130 cm in height will be excluded from the exercise test.

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Conditions

The condition(s) this trial relates to.

congenital heart disease hypoplastic left heart syndrome univentricular cardiopathy

As listed by the trial registrant

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

Heart defects

More trials for these conditions

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