Status:
TERMINATED
Heart Lung Machine Registry
Lead Sponsor:
Maquet Cardiopulmonary GmbH
Collaborating Sponsors:
NAMSA
Conditions:
Cardiac Surgery
Thoracic Surgery
Eligibility:
All Genders
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 / Pedi...
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...
Eligibility Criteria
Inclusion
- Signed Patient Informed Consent (including emergency approach)
- All patients who are connected to extracorporeal circulation using the index devices.
Exclusion
- Pregnancy
- Current participation or planned participation in a concurrent drug or interventional medical device study
Key Trial Info
Start Date :
December 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT06159517
Start Date
December 21 2023
End Date
April 30 2025
Last Update
December 26 2025
Active Locations (3)
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1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy
2
Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces)
Bilbao, Spain
3
Hospital Universitario Ramón y Cajal
Madrid, Spain