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A new roadmap to transplant: could standardizing care save more congenital heart patients?

NCT ID NCT07799272

Disease control Sponsor: CardioVision International Tech, S.A.S. de C.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests a structured care pathway called TORCH-ITAP in Latin America. The pathway standardizes how patients with congenital heart disease are identified, referred, evaluated, and matched for heart or lung transplants. Researchers will compare hospitals using the pathway to those using usual care, measuring whether more patients complete a transplant evaluation within 90 days. The goal is to reduce gaps in access and help more eligible patients reach transplant.

What this could mean

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

Active substance
TORCH Integrated Transplant Access Pathway (TORCH-ITAP), a health-services intervention that standardizes referral, evaluation, and organ-matching steps for transplant access
What this could lead to
If it works, this pathway could help more people with congenital heart disease get timely transplant evaluations and potentially receive life-saving heart or lung transplants.
What could go wrong
This is a health-services trial, not a drug test, so success depends on many hospitals adopting the pathway consistently. It may not overcome broader shortages of donor organs or differences in national transplant rules.

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 600 people

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

Expected to start

Mar 2027

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

0 days 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: * Confirmed congenital heart disease. * Age from birth with no protocol-defined upper age limit. * Advanced cardiac, pulmonary vascular, or cardiopulmonary deterioration meeting contemporary international criteria for transplant referral/evaluation, or previously documented transplant candidacy by an authorized program. * Clinical presentation within the TORCH scope: heart transplantation; heart-lung transplantation; or, in selected congenital heart disease, bilateral lung transplantation with cardiac repair after multidisciplinary adjudication. * Availability of the minimum baseline dataset required for standardized multidisciplinary evaluation and risk stratification. * Written informed consent from the participant or legally authorized representative, with assent and re-consent as applicable under local requirements. * Ability to undergo protocol-defined longitudinal follow-up. * For participants referred from a non-transplant site, an operational referral route within the participating network to at least one authorized transplant center must exist. Prior acceptance by that transplant center is not required for trial enrollment; completion of specialist evaluation and the candidacy decision are post-enrollment trial processes/outcomes. Exclusion Criteria: * Absence of congenital heart disease or a transplant indication outside the TORCH congenital-heart-disease scope. * No protocol-defined indication for transplant referral/evaluation after standardized review. * A contemporary absolute contraindication to all transplant strategies applicable to the participant that is confirmed by multidisciplinary adjudication and is not considered reversible or re-evaluable under the protocol. * Inability to obtain required informed consent/assent or to collect the minimum essential baseline dataset. * A legal, regulatory, or safety condition that prohibits participation in research at the enrolling site.

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Conditions

The condition(s) this trial relates to.

congenital heart disease

As listed by the trial registrant

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

Congenital heart disease

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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