MedPath

Safety and Performance Study of the CardioGard Cannula

Phase 2
Completed
Conditions
Aortic Valve Replacement
Registration Number
NCT01554709
Lead Sponsor
CardioGard Medical Ltd.
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
71
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
DWI- Diffusion Weighted ImagingThe outcome measure is assessed in average a week after the surgery

diffusion weighted magnetic resonance imaging (DW-MRI)

Secondary Outcome Measures
NameTimeMethod
TCD- Transcranial DopplerThe Outcome measure is assessed during the surgery

Trial Locations

Locations (5)

Kerckhoff Klinik

🇩🇪

Bad Nauheim, Germany

Heart Center Leipzig, University of Leipzig

🇩🇪

Leipzig, Germany

Rambam Health Care Campus

🇮🇱

Haifa, Israel

Insel Hospital

🇨🇭

Bern, Switzerland

University Hospital Zurich

🇨🇭

Zurich, Switzerland

Kerckhoff Klinik
🇩🇪Bad Nauheim, Germany

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.