Safety and Performance Study of the CardioGard Cannula

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554709

Enrollment

Registered

2012-03-15

Start date

2012-03-31

Completion date

2014-05-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Replacement

Keywords

bypass, cannula

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.

Interventions

DEVICEAortic Cannulas (CardioGard)

Comparison of aortic cannulas during by pass surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
TCD- Transcranial Doppler	The Outcome measure is assessed during the surgery

Countries

Germany, Israel, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026