Safety and Performance Study of the CardioGard Cannula

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CardioGard Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01554709
First received: March 11, 2012
Last updated: September 23, 2014
Last verified: September 2014

March 11, 2012
September 23, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.
 
Completed
71
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
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Israel,   Switzerland
 
NCT01554709
CLN0009
No
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