Cardiac SurgeryHeaLMeNCT06159517
Heart Lung Machine Registry
An observational study of Cardiac Surgery and Thoracic Surgery, run by Maquet Cardiopulmonary GmbH at 3 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery
- How many people
- 184 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 21 Dec 2023to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Signed Patient Informed Consent (including emergency approach)
- All patients who are connected to extracorporeal circulation using the index devices.
Who cannot join
- Pregnancy
- Current participation or planned participation in a concurrent drug or interventional medical device study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites
Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)
Bilbao
Hospital Universitario Ramón y Cajal
Madrid
About this study
Official title: 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.
Read the 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.
- Keywords
- Heart Lung Machine, HL 40, Temperature Probes, TPO-D-HLM L1.8 Adult, TPO-D-HLM L1.8 Pediatric
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Endpoint
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).
Measured: Only during the index procedure, no FU.
Safety Endpoint
The rate of index device(s) related Adverse Events during the index procedure.
Measured: Only during the index procedure, no FU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start21 Dec 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: The index device HL 40 has been discontinued
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maquet Cardiopulmonary GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Alejandro Crespo de Hubsch, Dr., Principal investigator, Hospital Universitario de Cruces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159517
- Sponsor's protocol ID
- 3110158
- Acronym
- HeaLMe
- Status last verified
- Dec 2025
- First submitted
- 28 Nov 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06159517
- Acronym / sponsor ID
- HeaLMe / 3110158
- Keywords
- Heart Lung Machine, HL 40, Temperature Probes, TPO-D-HLM L1.8 Adult, TPO-D-HLM L1.8 Pediatric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The index device HL 40 has been discontinued
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Maquet Cardiopulmonary GmbHIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Signed Patient Informed Consent (including emergency approach)
- All patients who are connected to extracorporeal circulation using the index devices.
Key exclusion criteria (2 listed)
- Pregnancy
- Current participation or planned participation in a concurrent drug or interventional medical device study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Safety Endpoint
Time frame: Only during the index procedure, no FU.
The rate of index device(s) related Adverse Events during the index procedure.
Results and safety
The study was stopped early (reason given: The index device HL 40 has been discontinued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alejandro Crespo de Hubsch, Dr. principal investigator
Hospital Universitario de Cruces
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Thoracic Surgery, run by Maquet Cardiopulmonary GmbH at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The index device HL 40 has been discontinued). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Endpoint (time frame: Only during the index procedure, no FU.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.