Heart Lung Machine Registry (HeaLMe)

December 19, 2025 updated by: Maquet Cardiopulmonary GmbH

Post-Market Clinical Follow-up Registry to Evaluate the Safety and Performance of the HL 40 Heart Lung Machine and the Temperature Probes in Patients Undergoing Cardiac / Thoracic / Vascular Surgery

The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing cardiac / thoracic / vascular surgery.

Study Overview

Status

Terminated

Conditions

Detailed Description

In this study, patients who are connected to the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric and undergo a cardiac / thoracic / vascular surgery will be observed. This includes neonates, infants, adolescents and adults regardless of age and underlying health condition. It also includes elective, urgent and emergent surgeries.

Data will be collected for each participant according to the study schedule and standard routine clinical practice at the enrolling centers. There will be no additional visits, nor procedures pertaining to the study itself for subjects who participate in the study.

Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected.

The period of data collection for each patient will be only the index procedure. The index procedure is defined as the investigator's planned initial procedure in which the patient is connected to the HL 40 and the Temperature Probes. The index procedure starts with the cannulation of the patient for the index procedure and ends with the de-cannulation of the patient.

Study Type

Observational

Enrollment (Actual)

184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Spain
      • Bilbao, Spain
        • Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance Endpoint
Time Frame: Only during the index procedure, no FU.
The rate of cases performed by the index devices during the index procedure without any failure and / or malfunction related to the index device(s).
Only during the index procedure, no FU.
Safety Endpoint
Time Frame: Only during the index procedure, no FU.
The rate of index device(s) related Adverse Events during the index procedure.
Only during the index procedure, no FU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maquet Cardiopulmonary GmbH

Collaborators

NAMSA

Investigators

  • Principal Investigator: Alejandro Crespo de Hubsch, Dr., Hospital Universitario de Cruces

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3110158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe