Heart Valve DiseasesGECGNCT02764645
Performance of the CARDIOGARD Cannula
A study testing CardioGard Cannula and 22Fr curved Cannula in people with Heart Valve Diseases and Coronary Artery Disease, run by Rambam Health Care Campus.
Trial summary
This is a single center, prospective study: The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Valve Diseases, Coronary Artery Disease
- What is being tested?
- CardioGard Cannula and 22Fr curved Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- May 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- CardioGard Cannula, 22Fr curved Cannula
- Keywords
- Cardiopulmonary Bypass
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioGard CannulaDevice
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.
22Fr curved CannulaDevice
arterial cannula for use in cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| CardioGard group | Experimental | 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'. Receives: Device: CardioGard Cannula |
| Control group | Active comparator | 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. Receives: Device: 22Fr curved Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 'CardioGard Cannula' Gaseous emboli capturing ability
The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .
Measured: 36 months
Secondary outcomes (2)
The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
Using the suction feature, External filters will be analyzed in order to recover particulate matter.
Measured: 36 months
The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
The ability of the Cardiogard cannula will be evaluated using Neurological questionnaires.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- CardioGard Medical Ltd.
- Responsible party
- Principal investigator, Gil Bolotin MD, Rambam Health Care Campus
- Investigators
- Gil - Bolotin, Prof., Principal investigator, Head of the Cardiac Surgery Department, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764645
- Sponsor's protocol ID
- CLNG100 Full Protocol
- Acronym
- GECG
- Status last verified
- May 2016
- First submitted
- 22 Mar 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The data of this research would be published as an article and will include all the relevant clinical outcomes related to the effect of gaseous emboli.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
- ClinicalTrials.gov ID
- NCT02764645
- Acronym / sponsor ID
- GECG / CLNG100 Full Protocol
- Conditions
- Heart Valve Diseases, Coronary Artery Disease
- Keywords
- Cardiopulmonary Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- CardioGard Medical Ltd.
- Study start
- May 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 6 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CardioGard group | Experimental | Device: CardioGard CannulaPatients 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'. |
| Control group | Active comparator | Device: 22Fr curved CannulaPatients 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioGard CannulaCardioGard 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 | CardioGard group |
| 22Fr curved Cannulaarterial cannula for use in cardiac surgery | Device | Control group |
Primary outcome
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. .
2 secondary outcomes
The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
Time frame: 36 months
The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
- Individual participant dataSharing planned: Yes. The data of this research would be published as an article and will include all the relevant clinical outcomes related to the effect of gaseous emboli.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil - Bolotin, Prof. principal investigator
Head of the Cardiac Surgery Department, Rambam Health Care Campus
Questions about this trial
What is this clinical trial studying?
A study testing CardioGard Cannula and 22Fr curved Cannula in people with Heart Valve Diseases and Coronary Artery Disease, run by Rambam Health Care Campus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roi - Glam, MD (+972-4-7772631, r_glam@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 'CardioGard Cannula' Gaseous emboli capturing ability (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2016.