Automated Fastener Device Versus Manually Tied Knot in MiAVR

NCT03664102 | Completed

• 1 other identifier: CCVT-MORGANT 082018
• Study Type: observational
• Target: 221
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• Cardiac surgery times

  Aortic cross-clamping and cardiopulmonary bypass times

  peroperative data

Secondary Outcomes (1)

• Morbimortality

  Perioperative (30 days) and 24 months follow up

Study Arms (2)

Sutures with hand-tied knots

Minimally-invasive isolated aortic valve replacement with Sutures were secured with hand-tied knots

Sutures with automated fastener device (Cor-Knot)

Minimally-invasive isolated aortic valve replacement with Sutures were secured with automated fastener device (Cor-Knot)

Device: Cor Knot

Interventions

Cor Knot DEVICE

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

Sutures with automated fastener device (Cor-Knot)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier La Chartreuse: lead

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: September 1, 2009
• Primary Completion: September 1, 2018
• Study Completion: September 6, 2018
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share