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OpenTrials
Completed

NCT Number: NCT03664102

Automated Fastener Device Versus Manually Tied Knot in MiAVR

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.

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cor Knot

Device

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

Primary outcomes

  1. Cardiac surgery times

    Time frame: peroperative data

    Aortic cross-clamping and cardiopulmonary bypass times

Secondary outcomes

  1. Morbimortality

    Time frame: Perioperative (30 days) and 24 months follow up

    Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation

Sponsors and collaborators

Lead sponsor

Centre Hospitalier La Chartreuse

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Sep 10, 2018
Registry last updated
Sep 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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