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Performance of the CARDIOGARD Cannula

NCT02764645 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2016-05-06

No results posted yet for this study

Summary

This is a single center, prospective study:

The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.

Conditions

Interventions

DEVICE

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.

DEVICE

22Fr curved Cannula

arterial cannula for use in cardiac surgery

Sponsors & Collaborators

  • CardioGard Medical Ltd.

    collaborator INDUSTRY

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-05-31
Completion
2019-05-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02764645 on ClinicalTrials.gov