Performance of the CARDIOGARD Cannula (GECG)

May 5, 2016 updated by: Gil Bolotin MD, Rambam Health Care Campus

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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'.

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.

Active Comparator: 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.
arterial cannula for use in cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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. .
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
Time Frame: 36 months
Using the suction feature, External filters will be analyzed in order to recover particulate matter.
36 months
The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
Time Frame: 36 months
The ability of the Cardiogard cannula will be evaluated using Neurological questionnaires.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Gil - Bolotin, Prof., Head of the Cardiac Surgery Department, Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2017

Study Completion (Anticipated)

May 1, 2019

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 5, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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