Performance of the CARDIOGARD Cannula

NCT ID: NCT02764645

Last Updated: 2016-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-05-31

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.

Conditions

Heart Valve Diseases; Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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'.

Group Type: EXPERIMENTAL

CardioGard Cannula

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

22Fr curved Cannula

Intervention Type: DEVICE

arterial cannula for use in cardiac surgery

Interventions

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.

Intervention Type: DEVICE

22Fr curved Cannula

arterial cannula for use in cardiac surgery

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CardioGard Medical Ltd.

INDUSTRY

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Gil Bolotin MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gil - Bolotin, Prof.

Role: PRINCIPAL_INVESTIGATOR

Head of the Cardiac Surgery Department, Rambam Health Care Campus

Central Contacts

Roi - Glam, MD

Role: CONTACT

r_glam@rambam.health.gov.il

+972-4-7772631

Daniel - Haber, MA

Role: CONTACT

d_haber@rambam.health.gov.il

+972-4-7772048

Other Identifiers

CLNG100 Full Protocol

Identifier Type: -

Identifier Source: org_study_id