NCT06159517

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
• Phase: —
• Study type: Observational
• Enrollment: 184 (actual)
• Sponsor: Maquet Cardiopulmonary GmbH · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery
• Thoracic Surgery
• Vascular Surgery
• Cardiopulmonary Bypass

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2023-12-06
• Last updated: 2025-12-26

Locations

3 sites across 2 countries: Italy, Spain