Automated Fastener Device Versus Manually Tied Knot in MiAVR

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03664102
• Other study ID #: CCVT-MORGANT 082018
• Status: Completed
• Start date: September 1, 2009
• Est. completion date: September 6, 2018

Study information

• Verified date: September 2018
• Source: Centre Hospitalier La Chartreuse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: September 6, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier La Chartreuse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac surgery times	Aortic cross-clamping and cardiopulmonary bypass times	peroperative data
Secondary	Morbimortality	Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation	Perioperative (30 days) and 24 months follow up