NCT06159517

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

December 21, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 26, 2025

Status Verified

December 1, 2025

Enrollment Period

1.4 years

First QC Date

November 28, 2023

Last Update Submit

December 19, 2025

Conditions

Cardiac SurgeryThoracic SurgeryVascular SurgeryCardiopulmonary Bypass

Keywords

Heart Lung MachineHL 40Temperature ProbesTPO-D-HLM L1.8 AdultTPO-D-HLM L1.8 Pediatric

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Safety Endpoint

    The rate of index device(s) related Adverse Events during the index procedure.

    Only during the index procedure, no FU.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Signed Patient Informed Consent (including emergency approach)
  • All patients who are connected to extracorporeal circulation using the index devices.

You may not qualify if:

  • Pregnancy
  • Current participation or planned participation in a concurrent drug or interventional medical device study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Location

Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)

Bilbao, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Study Officials

  • Alejandro Crespo de Hubsch, Dr.

    Hospital Universitario de Cruces

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 6, 2023

Study Start

December 21, 2023

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 26, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)ES(2)