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This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
Full 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.
Enrollment
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Inclusion criteria
Exclusion criteria
Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal.
Patient with an aortic trauma.
Patient contraindicated for open heart surgery under bypass machine.
Patient undergoing a re-do procedure.
Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy)
Patient with pathologies which affect his/her neurological condition.
Patient in whom emergency operation is required.
Patient with a known allergy to Heparin
Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to:
Current use of drugs that might result in high surgical risk or significant postoperative complication.
Psychological instability, inappropriate attitude or motivation.
Patients with life threatening debilitating disease other than cardiac.
Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints.
Primary purpose
Allocation
Interventional model
Masking
400 participants in 2 patient groups
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Central trial contact
Roi - Glam, MD; Daniel - Haber, MA
Data sourced from clinicaltrials.gov
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