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Automated Fastener Device Versus Manually Tied Knot in MiAVR

NCT03664102 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 221

Last updated 2018-09-10

No results posted yet for this study

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

DEVICE

Cor Knot

Heart valve replacement with or without the use of automated fastener device Cor Knot

Sponsors & Collaborators

  • Centre Hospitalier La Chartreuse

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-01
Primary Completion
2018-09-01
Completion
2018-09-06

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03664102 on ClinicalTrials.gov