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Completed

NCT Number: NCT01554709

Safety and Performance Study of the CardioGard Cannula

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

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Key information

Conditions

Aortic Valve Replacement

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Kerckhoff Klinik, Bad Nauheim, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aortic Cannulas (CardioGard)

Device

Comparison of aortic cannulas during by pass surgery

Primary outcomes

  1. DWI- Diffusion Weighted Imaging

    Time frame: The outcome measure is assessed in average a week after the surgery

    diffusion weighted magnetic resonance imaging (DW-MRI)

Secondary outcomes

  1. TCD- Transcranial Doppler

    Time frame: The Outcome measure is assessed during the surgery

Sponsors and collaborators

Lead sponsor

CardioGard Medical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 15, 2012
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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