Clinical trial NCT02764645: Performance of the CARDIOGARD Cannula
Official title: A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Diseases
Coronary Artery Disease
Keywords: Cardiopulmonary Bypass
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: CardioGard Medical Ltd.
First posted: 2016-05-06
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours.
2. 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).
3. The patient is \>50 and \<85 years of age.
4. The patient's body weight is compatible with blood net flow of 4 - 5 \[l/min\].
5. Patient with left ventricular ejection fraction \>30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA)
6. The patient is willing to participate as evidenced by signing the written informed consent.
7. Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test)

Exclusion Criteria:

1. Patient with abnormal clotting mechanism: PT 60%, PTT\>2 the normal.
2. Patient with an aortic trauma.
3. Patient contraindicated for open heart surgery under bypass machine.
4. Patient undergoing a re-do procedure.
5. Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy)
6. Patient with pathologies which affect his/her neurological condition.
7. Patient in whom emergency operation is required.
8. Patient with a known allergy to Heparin
9. 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 \[20\]
10. Current use of drugs that might result in high surgical risk or significant postoperative complication.
11. Psychological instability, inappropriate attitude or motivation.
12. Patients with life threatening debilitating disease other than cardiac.
13. 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 outcomes:
measure: The 'CardioGard Cannula' Gaseous emboli capturing ability
timeFrame: 36 months
Secondary outcomes:
measure: The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
timeFrame: 36 months
measure: The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
timeFrame: 36 months
Other outcomes:
Locations:
Study officials:
affiliation: Head of the Cardiac Surgery Department, Rambam Health Care Campus
name: Gil - Bolotin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: