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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06159517
Other study ID # 3110158
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 21, 2023
Est. completion date June 2025

Study information

Verified date April 2024
Source Maquet Cardiopulmonary GmbH
Contact Stephanie Beltz, Dr.
Phone +49 174 919 2865
Email stephanie.beltz@getinge.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date June 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
Spain Organización Sanitaria Integrada Ezkerraldea-Enkarterri-Cruces (Centro sanitario Hospital Universitario Cruces) Bilbao
Spain Hospital Universitario Ramón y Cajal Madrid

Sponsors (2)

Lead Sponsor Collaborator
Maquet Cardiopulmonary GmbH NAMSA

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Performance Endpoint The rate of cases performed by the index devices during the index procedure without any failure and / or malfunction related to the index device(s). Only during the index procedure, no FU.
Primary Safety Endpoint The rate of index device(s) related Adverse Events during the index procedure. Only during the index procedure, no FU.
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