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Automated Fastener Device Versus Manually Tied Knot in MiAVR

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ClinicalTrials.gov Identifier: NCT03664102
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse

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.


Condition or disease Intervention/treatment
Heart Valve Diseases Device: Cor Knot

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Study Type : Observational
Actual Enrollment : 221 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery
Actual Study Start Date : September 1, 2009
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 6, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Heart valve replacement with or without the use of automated fastener device Cor Knot




Primary Outcome Measures :
  1. Cardiac surgery times [ Time Frame: peroperative data ]
    Aortic cross-clamping and cardiopulmonary bypass times


Secondary Outcome Measures :
  1. Morbimortality [ Time Frame: Perioperative (30 days) and 24 months follow up ]
    Morbidity (Stroke, pacemaker implantation, aortic regurgitation) Death Valve-related reoperation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

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Responsible Party: MORGANT Marie-Catherine, Principal investigator, Centre Hospitalier La Chartreuse
ClinicalTrials.gov Identifier: NCT03664102     History of Changes
Other Study ID Numbers: CCVT-MORGANT 082018
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Trial on medical records only. No specific regulatory authorization required. The trial has already been recorded as Professionnal evaluation practices.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases