Clinical trial NCT06159517: Heart Lung Machine Registry
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery
Thoracic Surgery
Vascular Surgery
Cardiopulmonary Bypass
Keywords: Heart Lung Machine
HL 40
Temperature Probes
TPO-D-HLM L1.8 Adult
TPO-D-HLM L1.8 Pediatric
Lead sponsor: Maquet Cardiopulmonary GmbH
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2023-12-06
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Performance Endpoint
timeFrame: Only during the index procedure, no FU.
measure: Safety Endpoint
timeFrame: Only during the index procedure, no FU.
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Bilbao
country: Spain
facility: Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
Study officials:
affiliation: Hospital Universitario de Cruces
name: Alejandro Crespo de Hubsch, Dr.
role: PRINCIPAL_INVESTIGATOR
References: