A prospective, Phase 1, open treatment, non comparative, single centre, device study to evaluate the safety and performance of the MTMM bi-directional cannula in patients requiring peripheral cannulation for Cardiac Surgery.

Alfred Hospital0 sites15 target enrollmentSeptember 28, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Alfred Hospital
Enrollment: 15
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This trial demonstrates that the novel bi-directional cannula is safe and easy to insert in the femoral artery and provides stable blood flow down the leg during cardiopulmonary bypass. The use of this device should largely remove the need to insert a separate cannula to provide blood flow down the leg, or use other techniques to protect against insufficient blood flow.

Registry

who.int

Start Date

September 28, 2015

End Date

July 7, 2017

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Alfred Hospital

Eligibility Criteria

Inclusion Criteria

•1\. Patients may be male or female
•2\. Patients must be 18 years or over and not more than 80 years of age.
•3\. Patients must be assessed as requiring cardiac surgery with cardiopulmonary bypass support by a cardio\-thoracic surgeon.
•4\. Patients must weigh greater than 45kg and less than 130kg.
•5\. Site personnel must obtain informed consent from the patient prior to any study procedures (including screening procedures).

Exclusion Criteria

•1\. Patients who have undergone previous vascular surgery of the femoral artery.
•2\. Patients requiring emergency cardiac surgery including Type A aortic dissections.
•3\. Patients where the internal diameter of the common femoral artery is not greater than 0\.6cm.
•4\. Concurrent enrollment in another investigational drug or device study, or use of any experimental or investigational drug or device within 30 days of cardiopulmonary bypass support.
•5\. Any other medical condition which in the view if the Investigator is likely to interfere with the study or put the patient at risk.
•6\. Patients who the investigator feels will not achieve adequate flow rates and line pressures due to the patient's weight and body surface area.