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Novel Bidirectional Peripheral Artery Cannula in Minimally Invasive Aortic Valve Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04402372
Enrollment
60
Registered
2020-05-26
Start date
2020-03-01
Completion date
2020-06-15
Last updated
2020-05-26

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

Conditions

Efficacy and Safety of Novel Bidirectional Cannula

Keywords

cannula, cardiopulmonary bypass, bidirectional

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

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 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

Interventions

DEVICENovel 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

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Vascular complicationsone mothinfection, emboli, hematoma, bleeding

Countries

Turkey (Türkiye)

Contacts

Primary ContactSerdar Gunaydin, MD
serdarkvc@gmail.com905363896521

Outcome results

None listed

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