Heart Lung Machine Registry

Cardiac Surgery Clinical Trial

— HeaLMe  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06159517
• Other study ID #: 3110158
• Status: Recruiting
• Start date: December 21, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Maquet Cardiopulmonary GmbH
• Contact: Stephanie Beltz, Dr.
• Phone: +49 174 919 2865
• Email: stephanie.beltz[@]getinge.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Spain	Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)	Bilbao
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Maquet Cardiopulmonary GmbH	NAMSA

Country where clinical trial is conducted

Spain, 

Outcome

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