Performance of the CARDIOGARD Cannula (GECG)

Rambam Health Care Campus

Status: Unknown

Conditions: Heart Valve Diseases; Coronary Artery Disease

Treatments: Device: 22Fr curved Cannula; Device: CardioGard Cannula

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02764645

CLNG100 Full Protocol

Details and patient eligibility

About

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: 400 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

CardioGard group

Experimental group

Description:

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'.

Treatment:

Device: CardioGard Cannula

Control group

Active Comparator group

Description:

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.

Treatment:

Device: 22Fr curved Cannula