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Safety and Performance Study of the CardioGard Cannula

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01554709
First Posted: March 15, 2012
Last Update Posted: September 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CardioGard Medical Ltd.
  Purpose
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 (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554709


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

Responsible Party: CardioGard Medical Ltd.
ClinicalTrials.gov Identifier: NCT01554709     History of Changes
Other Study ID Numbers: CLN0009
First Submitted: March 11, 2012
First Posted: March 15, 2012
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by CardioGard Medical Ltd.:
bypass
cannula