- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02764645
Performance of the CARDIOGARD Cannula (GECG)
A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roi - Glam, MD
- Phone Number: +972-4-7772631
- Email: r_glam@rambam.health.gov.il
Study Contact Backup
- Name: Daniel - Haber, MA
- Phone Number: +972-4-7772048
- Email: d_haber@rambam.health.gov.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours.
- Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG).
- The patient is >50 and <85 years of age.
- The patient's body weight is compatible with blood net flow of 4 - 5 [l/min].
- Patient with left ventricular ejection fraction >30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA)
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test)
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:
- previous stroke
- critical preoperative state
- poor ventricular function
- severe pulmonary hypertension [19]
- Atheroembolism
- history of cardiac failure [20]
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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'. |
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.
|
arterial cannula for use in cardiac surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. .
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 months
|
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.
|
36 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gil - Bolotin, Prof., Head of the Cardiac Surgery Department, Rambam Health Care Campus
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLNG100 Full Protocol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on CardioGard Cannula
-
Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCoronary Artery Disease | Delirium | Ischemic Stroke | Acute Kidney Injury | Heart Valve DiseaseUnited States, Canada
-
Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI)CompletedStroke | Aortic Stenosis | Brain Infarction | Cerebrovascular AccidentUnited States, Canada
-
CardioGard Medical Ltd.CompletedAortic Valve ReplacementIsrael, Switzerland, Germany
-
Vapotherm, Inc.VA Pittsburgh Healthcare System; Erlanger Baroness HospitalCompletedRespiratory Insufficiency | Dyspnea | HypercapniaUnited States
-
Manchester University NHS Foundation TrustCompletedPreterm InfantUnited Kingdom
-
Montefiore Medical CenterCompletedMorbid Obesity | Noninvasive Ventilation | Deep SedationUnited States
-
Aga Khan University Hospital, PakistanUnknownApneic Oxygenation
-
Haichao LiCompleted
-
Chang Gung UniversityCompletedChronic Obstructive Pulmonary DiseaseTaiwan