Automated Fastener Device Versus Manually Tied Knot in MiAVR

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Heart Valve Diseases

Clinical Trial Details

NCT number	NCT03664102
Study type	Observational
Source	Centre Hospitalier La Chartreuse
Contact
Status	Completed
Phase
Start date	September 1, 2009
Completion date	September 6, 2018

View Details

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