Registry for Heart Lung Machine and Temperature Probes in Surgery
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
This study is testing the safety and performance of a heart-lung machine and temperature probes in patients of all ages undergoing various types of surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | Maquet Cardiopulmonary GmbH Industry-sponsored |
| Locations | 3 sites (Rome and 2 other locations) |
| Trial ID | NCT06159517 on ClinicalTrials.gov |
What this trial studies
This observational registry aims to evaluate the safety and performance of the Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 in patients undergoing cardiac, thoracic, or vascular surgeries. Participants will be observed during their index procedures, which include a range of patients from neonates to adults, regardless of their health conditions. Data will be collected according to standard clinical practices without additional study-related visits or procedures. Informed consent will be obtained from all participants to utilize their clinical records for this purpose.
Who should consider this trial
Good fit: Ideal candidates include patients of all ages undergoing cardiac, thoracic, or vascular surgeries who will be connected to the Heart Lung Machine and Temperature Probes.
Not a fit: Patients who are pregnant or currently participating in other concurrent drug or interventional medical device studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance the understanding of the safety and effectiveness of these devices in surgical settings, potentially improving patient outcomes.
How similar studies have performed: Other observational studies have successfully evaluated similar medical devices, indicating a precedent for this type of registry.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Rome and 2 other locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Recruiting)
- Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces) — Bilbao, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
Study contacts
- Principal investigator: Alejandro Crespo de Hubsch, Dr. — Hospital Universitario de Cruces
- Study coordinator: Stephanie Beltz, Dr.
- Email: stephanie.beltz@getinge.com
- Phone: +49 174 919 2865
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.