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NCT01554709 Clinical Trial

Safety and Performance Study of the CardioGard Cannula

Aortic Valve Replacement Clinical Trial

Official title:
A Study to Collect Additional Information Related to the Safety and Performance of the CardioGard Cannula

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01554709
Other study ID # CLN0009
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received March 11, 2012
Last updated September 23, 2014
Start date March 2012
Est. completion date May 2014

Study information
Verified date September 2014
Source CardioGard Medical Ltd.
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics CommissionIsrael: Ministry of HealthSwitzerland: EthikkommissionSwitzerland: SwissmedicGermany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 71
Est. completion date May 2014
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 85 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Aortic Cannulas (CardioGard)
Comparison of aortic cannulas during by pass surgery

Locations
Country Name City State
Germany Kerckhoff Klinik Bad Nauheim
Germany Heart Center Leipzig, University of Leipzig Leipzig
Israel Rambam Health Care Campus Haifa
Switzerland Insel Hospital Bern
Switzerland University Hospital Zurich Zurich

Sponsors (1)
Lead Sponsor Collaborator
CardioGard Medical Ltd.

Countries where clinical trial is conducted

Germany,  Israel,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary DWI- Diffusion Weighted Imaging diffusion weighted magnetic resonance imaging (DW-MRI) The outcome measure is assessed in average a week after the surgery No
Secondary TCD- Transcranial Doppler The Outcome measure is assessed during the surgery No
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