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Safety and Performance Study of the CardioGard Cannula

This study has been completed.
Information provided by (Responsible Party):
CardioGard Medical Ltd. Identifier:
First received: March 11, 2012
Last updated: September 23, 2014
Last verified: September 2014
The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.

Condition Intervention Phase
Aortic Valve Replacement
Device: Aortic Cannulas (CardioGard)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula

Further study details as provided by CardioGard Medical Ltd.:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • TCD- Transcranial Doppler [ Time Frame: The Outcome measure is assessed during the surgery ]

Enrollment: 71
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01554709

Kerckhoff Klinik
Bad Nauheim, Germany
Heart Center Leipzig, University of Leipzig
Leipzig, Germany
Rambam Health Care Campus
Haifa, Israel, 31096
Insel Hospital
Bern, Switzerland
University Hospital Zurich
Zurich, Switzerland
Sponsors and Collaborators
CardioGard Medical Ltd.
Principal Investigator: Gil Bolotin, Dr. Rambam Health Care Campus
  More Information

Responsible Party: CardioGard Medical Ltd. Identifier: NCT01554709     History of Changes
Other Study ID Numbers: CLN0009
Study First Received: March 11, 2012
Last Updated: September 23, 2014

Keywords provided by CardioGard Medical Ltd.:
cannula processed this record on April 28, 2017