NCT03664102

Automated Fastener Device Versus Manually Tied Knot in MiAVR

Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 221 (actual)
• Sponsor: Centre Hospitalier La Chartreuse · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT). Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158. The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	Cor Knot	Heart valve replacement with or without the use of automated fastener device Cor Knot

Timeline

• Start date: 2009-09-01
• Primary completion: 2018-09-01
• Completion: 2018-09-06
• First posted: 2018-09-10
• Last updated: 2018-09-10