Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

Efficacy and Safety of Novel Bidirectional Cannula Clinical Trial

Official title:

Comparative Clinical Efficacy of Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04402372
• Other study ID #: 2020-1994
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: June 15, 2020

Study information

• Verified date: May 2020
• Source: Ankara City Hospital Bilkent
• Contact: Serdar Gunaydin, MD
• Phone: 905363896521
• Email: serdarkvc[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 conventional cannula with downstream line in patients undergoing femoral arterial cannulation for cardiopulmonary bypass during minimally invasive surgery

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 procedures, and procedures involving the thoracic aorta Limb ischemia is the most common acute and late vascular complication and has been reported in 10% to 70% of patients Traditional methods to maintain distal perfusion include the use of a downstream cannula or sewing on a side graft, but these techniques are cumbersome, time-consuming, and require additional equipment As a result, current practice is relying on the very small volume of blood that will flow around the cannula and collateral circulation to keep the leg viable, but by the time ischemia is clinically evident, irreversible cell damage may have already occurred 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 conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during MICS

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2020
• Est. primary completion date: June 15, 2020
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patient undergoing minimally invasvie aortic valve replacement 50-90 years of age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Efficacy and Safety of Novel Bidirectional Cannula

Intervention

Device:
• Novel bidirectional cannula (BiflowTM, LivaNova, Italy)
We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery

Locations

Country	Name	City	State
Turkey	Ankara City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Marasco SF, Tutungi E, Vallance SA, Udy AA, Negri JC, Zimmet AD, McGiffin DC, Pellegrino VA, Moshinsky RA. A Phase 1 Study of a Novel Bidirectional Perfusion Cannula in Patients Undergoing Femoral Cannulation for Cardiac Surgery. Innovations (Phila). 2018 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular complications	infection, emboli, hematoma, bleeding	one moth