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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiac Surgery
- Sponsor
- Maquet Cardiopulmonary GmbH
- Enrollment
- 184
- Locations
- 3
- Primary Endpoint
- Safety Endpoint
- Status
- Terminated
- Last Updated
- 4 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Safety Endpoint
Time Frame: Only during the index procedure, no FU.
The rate of index device(s) related Adverse Events during the index procedure.
Performance Endpoint
Time Frame: Only during the index procedure, no FU.
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).