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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03664102

Enrollment

221

Registered

2018-09-10

Start date

2009-09-01

Completion date

2018-09-06

Last updated

2018-09-10

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

Conditions

Heart Valve Diseases

Brief 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.

Interventions

DEVICECor Knot

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* age \> 18 years * Elective patient * Isolated aortic valve replacement with stented prosthesis * Minimally-invasive approach (right anterior minithoracotomy)

Exclusion criteria

* Associated procedure * Aortic valve replacement with sutureless or rapid valve deployment prosthesis * Active endocarditis * Prior cardiac surgery

Design outcomes

Primary

Measure	Time frame	Description
Cardiac surgery times	peroperative data	Aortic cross-clamping and cardiopulmonary bypass times

Secondary

Measure	Time frame	Description
Morbimortality	Perioperative (30 days) and 24 months follow up	Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation

Outcome results

None listed

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