TerminatedNot Applicable

Heart Lung Machine Registry

Stopped: The index device HL 40 has been discontinued

Italy, Spain184 participantsStarted 2023-12-21

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Performance Endpoint

Timeframe: Only during the index procedure, no FU.

Safety Endpoint

Timeframe: Only during the index procedure, no FU.

Trial details

NCT IDNCT06159517

SponsorMaquet Cardiopulmonary GmbH

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-04-30

View on ClinicalTrials.gov More Cardiac Surgery trials