Safety and Performance Study of the CardioGard Cannula

Phase 2

Completed

• Conditions: Aortic Valve Replacement
• Interventions: Device: Aortic Cannulas (CardioGard)

• 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

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-15
• Primary Completion: 2013-12
• Study Completion: 2014-05
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-23
• Last Update Posted: 2014-09-25

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

Arm && Interventions

Group	Intervention	Description
CardioGard Cannula	Aortic Cannulas (CardioGard)	-
Reference Cannula	Aortic Cannulas (CardioGard)	-

Primary Outcome Measures

Name	Time	Method
DWI- Diffusion Weighted Imaging	The outcome measure is assessed in average a week after the surgery	diffusion weighted magnetic resonance imaging (DW-MRI)

Secondary Outcome Measures

Name	Time	Method
TCD- Transcranial Doppler	The Outcome measure is assessed during the surgery

Trial Locations

Locations (5)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Kerckhoff Klinik; 🇩🇪 Bad Nauheim, Germany

Insel Hospital; 🇨🇭 Bern, Switzerland

University Hospital Zurich; 🇨🇭 Zurich, Switzerland

Heart Center Leipzig, University of Leipzig; 🇩🇪 Leipzig, Germany