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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
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Aortic Valve Replacement Device: Aortic Cannulas (CardioGard) Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
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
Study Start Date : March 2012
Primary Completion Date : December 2013
Study Completion Date : May 2014
Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. TCD- Transcranial Doppler [ Time Frame: The Outcome measure is assessed during the surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: March 15, 2012    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014

Keywords provided by CardioGard Medical Ltd.:
bypass
cannula