Performance of the CARDIOGARD Cannula

NCT02764645 | Unknown DMC

• 1 other identifier: CLNG100 Full Protocol
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single center, prospective study: The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.

Conditions

Heart Valve Diseases; Coronary Artery Disease

Keywords

Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• The 'CardioGard Cannula' Gaseous emboli capturing ability

  The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .

  36 months

Secondary Outcomes (2)

• The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula

  36 months

• The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.

  36 months

Study Arms (2)

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'.

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.

Device: 22Fr curved Cannula

Interventions

CardioGard Cannula 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.

CardioGard group

22Fr curved Cannula DEVICE

arterial cannula for use in cardiac surgery

Control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 \[20\]

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• CardioGard Medical Ltd.: collaborator

MeSH Terms

Conditions

Heart Valve Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gil - Bolotin, Prof.

  Head of the Cardiac Surgery Department, Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roi - Glam, MD

CONTACT

+972-4-7772631; r_glam@rambam.health.gov.il

Daniel - Haber, MA

CONTACT

+972-4-7772048; d_haber@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: May 6, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2019
• Last Updated: May 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share