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Heart Lung Machine Registry

NCT ID: NCT06159517

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

184 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-21

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiac Surgery Thoracic Surgery Vascular Surgery Cardiopulmonary Bypass

Keywords

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Heart Lung Machine HL 40 Temperature Probes TPO-D-HLM L1.8 Adult TPO-D-HLM L1.8 Pediatric

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NAMSA

OTHER

Sponsor Role collaborator

Maquet Cardiopulmonary GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alejandro Crespo de Hubsch, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Cruces

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status

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

Bilbao, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Countries

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Italy Spain

Other Identifiers

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3110158

Identifier Type: -

Identifier Source: org_study_id