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Safety and Performance Study of the CardioGard Cannula

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ClinicalTrials.gov Identifier: NCT01554709
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
CardioGard Medical Ltd.

March 11, 2012
March 15, 2012
September 25, 2014
March 2012
December 2013   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01554709 on ClinicalTrials.gov Archive Site
TCD- Transcranial Doppler [ Time Frame: The Outcome measure is assessed during the surgery ]
Same as current
Not Provided
Not Provided
Safety and Performance Study of the CardioGard Cannula
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Aortic Valve Replacement
Device: Aortic Cannulas (CardioGard)
Comparison of aortic cannulas during by pass surgery
  • Experimental: CardioGard Cannula
    Intervention: Device: Aortic Cannulas (CardioGard)
  • Active Comparator: Reference Cannula
    Intervention: Device: Aortic Cannulas (CardioGard)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Germany,   Israel,   Switzerland
Not Provided
Not Provided
CardioGard Medical Ltd.
CardioGard Medical Ltd.
Not Provided
Principal Investigator: Gil Bolotin, Dr. Rambam Health Care Campus
CardioGard Medical Ltd.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP