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
  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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
    diffusion weighted magnetic resonance imaging (DW-MRI)


Secondary Outcome Measures:
  • TCD- Transcranial Doppler [ Time Frame: The Outcome measure is assessed during the surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: CardioGard Medical Ltd.
ClinicalTrials.gov Identifier: NCT01554709     History of Changes
Other Study ID Numbers: CLN0009
Study First Received: March 11, 2012
Last Updated: September 23, 2014
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health
Switzerland: Ethikkommission
Switzerland: Swissmedic
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by CardioGard Medical Ltd.:
bypass
cannula

ClinicalTrials.gov processed this record on October 02, 2014