Heart Lung Machine Registry

Last updated: August 23, 2024
Sponsor: Maquet Cardiopulmonary GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Surgery

Spinal Surgery

Thoracotomy

Treatment

N/A

Clinical Study ID

NCT06159517
3110158
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed Patient Informed Consent (including emergency approach)

  • All patients who are connected to extracorporeal circulation using the indexdevices.

Exclusion

Exclusion Criteria:

  • Pregnancy

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

Study Design

Total Participants: 600
Study Start date:
December 21, 2023
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome,
    Italy

    Active - Recruiting

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

    Bilbao,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid,
    Spain

    Active - Recruiting

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