NCT02764645

Performance of the CARDIOGARD Cannula

A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a single center, prospective study: The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.

Detailed description

Patients referred for CPB procedure will be offered to participate in the study. Patients will be asked to sign an informed consent form (ICF), prior to performing any study related procedures. The point of enrollment is the time at which a patient signs and dates the ICF. Following enrollment, the patient will undergo screening evaluation (including Neurological assessment) to determine eligibility. Screening failures will be identified on a screening log. Patients who are found to meet all inclusion criteria and none of the exclusion criteria will compose the evaluable cohort of the study. Screening failure subjects will not be counted as part of the target patient sample size nor will they be included in the analysis. Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator cannulae and will remain blinded to their group assignment through the 30 days follow-up evaluation.

Conditions

• Heart Valve Diseases
• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CardioGard Cannula	CardioGard Cannula is a specially designed arterial (aortic) cannula for use in cardiac surgery for the purpose of removal of gaseous and solid embolic material emanating during the CPB procedure. The CardioGard cannula is a double lumen cannula where the primary lumen provides blood from the heart-lung machine similar to ordinary cannulas and the secondary lumen performs suction of blood and embolic matter away from the aortic arch and back to the cardiopulmonary bypass machine for filtration.
DEVICE	22Fr curved Cannula	arterial cannula for use in cardiac surgery

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-01
• Completion: 2019-05-01
• First posted: 2016-05-06
• Last updated: 2016-05-06