Performance of the CARDIOGARD Cannula (GECG)
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|ClinicalTrials.gov Identifier: NCT02764645|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2016
Last Update Posted : May 6, 2016
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
|Condition or disease||Intervention/treatment||Phase|
|Heart Valve Diseases Coronary Artery Disease||Device: CardioGard Cannula Device: 22Fr curved Cannula||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2019|
Experimental: CardioGard group
Patients in whom the CardioGard Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in two points: 1. The aortic vent.
2. The suction cannula of the 'Cardiogard cannula'.
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.
Active Comparator: Control group
Patients in whom a 22Fr curved Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in the aortic vent alone.
Device: 22Fr curved Cannula
arterial cannula for use in cardiac surgery
- The 'CardioGard Cannula' Gaseous emboli capturing ability [ Time Frame: 36 months ]The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .
- The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula [ Time Frame: 36 months ]Using the suction feature, External filters will be analyzed in order to recover particulate matter.
- The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery. [ Time Frame: 36 months ]The ability of the Cardiogard cannula will be evaluated using Neurological questionnaires.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02764645
|Contact: Roi - Glam, MDfirstname.lastname@example.org|
|Contact: Daniel - Haber, MAemail@example.com|
|Principal Investigator:||Gil - Bolotin, Prof.||Head of the Cardiac Surgery Department, Rambam Health Care Campus|