Status:
UNKNOWN
Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery
Lead Sponsor:
Ankara City Hospital Bilkent
Conditions:
Efficacy and Safety of Novel Bidirectional Cannula
Eligibility:
All Genders
50-90 years
Brief Summary
The aim of this study is to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventio...
Detailed Description
The femoral artery is a common site for peripheral cannulation in patients requiring cardiopulmonary bypass (CPB) for minimally invasive cardiac surgical procedures (MICS), redo cardiac surgical proce...
Eligibility Criteria
Inclusion
- Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age
Exclusion
- previous vascular surgery of the femoral artery, emergency cardiac surgery including type A aortic dissections, internal diameter of the common femoral artery less than 7.5 mm and where the clinician felt adequate flow rates and line pressures would not be achievable with a 19F cannula, because of the patient's weight and body surface area
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 15 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04402372
Start Date
March 1 2020
End Date
June 15 2020
Last Update
May 26 2020
Active Locations (1)
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1
Ankara City Hospital
Ankara, Turkey (Türkiye), 06100