Safety and Performance Study of the CardioGard Cannula

September 23, 2014 updated by: CardioGard Medical Ltd.

A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula

The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Locations

  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff Klinik
      • Leipzig, Germany
        • Heart Center Leipzig, University of Leipzig
  • Israel
      • Haifa, Israel, 31096
        • Rambam Health Care Campus
  • Switzerland
      • Bern, Switzerland
        • Insel Hospital
      • Zurich, Switzerland
        • University Hospital Zurich

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AVR (Aortic Valve Replacement), AVR+CABG (Coronary Artery Bypass Surgery)
  • Non pregnant female

Exclusion Criteria:

  • Contraindication for open heart surgery under bypass machine
  • Emergency Operation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CardioGard Cannula
Device: Aortic Cannulas (CardioGard)
Comparison of aortic cannulas during by pass surgery
Active Comparator: Reference Cannula
Device: Aortic Cannulas (CardioGard)
Comparison of aortic cannulas during by pass surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DWI- Diffusion Weighted Imaging
Time Frame: The outcome measure is assessed in average a week after the surgery
diffusion weighted magnetic resonance imaging (DW-MRI)
The outcome measure is assessed in average a week after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
TCD- Transcranial Doppler
Time Frame: The Outcome measure is assessed during the surgery
The Outcome measure is assessed during the surgery

Collaborators and Investigators

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

Sponsor

CardioGard Medical Ltd.

Investigators

  • Principal Investigator: Gil Bolotin, Dr., 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

March 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 11, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 15, 2012

Study Record Updates

Last Update Posted (Estimate)

September 25, 2014

Last Update Submitted That Met QC Criteria

September 23, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CLN0009

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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