Heart Lung Machine Registry

Recruiting

• Conditions: Cardiac Surgery; Thoracic Surgery; Vascular Surgery; Cardiopulmonary Bypass

• Registration Number: NCT06159517
• Lead Sponsor: Maquet Cardiopulmonary GmbH

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.

Study Timeline

• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-11-28
• Study First Posted: 2023-12-06
• Study Start: 2023-12-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety Endpoint	Only during the index procedure, no FU.	The rate of index device(s) related Adverse Events during the index procedure.
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).

Trial Locations

Locations (3)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Rome, Italy

Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces); 🇪🇸 Bilbao, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain