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Heart-Lung machine registry ends early – no major findings

NCT ID NCT06159517

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry studied the safety and performance of the HL 40 heart-lung machine and its temperature probes in 184 patients having heart, chest, or blood vessel surgery. The goal was to see how often the devices worked without failure or caused related side effects. The study was terminated early, so results are limited.

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

184 people

The number who actually took part.

Started

Dec 2023

Finished

Apr 2025

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.

Who is studied

All eligible patients who are connected to the index devices and undergo a cardiac / thoracic / vascular surgery. This includes neonates, infants, adolescents and adults regardless of age and underlying health condition. It also includes elective, urgent and emergent surgeries.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Signed Patient Informed Consent (including emergency approach) * All patients who are connected to extracorporeal circulation using the index devices. Exclusion Criteria: * Pregnancy * Current participation or planned participation in a concurrent drug or interventional medical device study

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Italy

  • Hospital Universitario Ramón y Cajal

    Madrid, Spain

  • Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)

    Bilbao, Spain

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