Heart Lung Machine Registry

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06159517

Acronym

HeaLMe

Enrollment

184

Registered

2023-12-06

Start date

2023-12-21

Completion date

2025-04-30

Last updated

2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Cardiopulmonary Bypass, Thoracic Surgery, Vascular Surgery

Keywords

Heart Lung Machine, HL 40, Temperature Probes, TPO-D-HLM L1.8 Adult, TPO-D-HLM L1.8 Pediatric

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Performance Endpoint	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	Only during the index procedure, no FU.	The rate of index device(s) related Adverse Events during the index procedure.

Countries

Italy, Spain

Outcome results