Multi-center Register for the Use of the Cor-Knot® Automated Knotting System in Heart Valve Surgery

NCT ID: NCT03681834

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

557 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-13

Study Completion Date

2021-03-25

Brief Summary

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The Cor-Knot® device is an automated knotting system for valve sutures and prosthetic rings used for more than a year during valve replacements and annuloplasties in cardiac surgery. It reduces the time spent knotting the threads fixing the prosthesis and thus reduces aortic clamping and extracorporeal circulation times. The originality of the project is based on the absence of national multi-rate data collection on the effectiveness and safety of the Cor-Knot® knotting device.

Detailed Description

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Conditions

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Vascular Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Data collection

Data on the effectiveness and safety of the Cor-Knot® knotting device

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* programmed minimally invasive surgery for:

* aortic valve replacement
* mitral valve replacement
* mitral valve plastic surgery
* adult patient

Exclusion Criteria

* emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chu Dijon Bourogne

Dijon, , France

Site Status

Countries

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France

References

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Morgant MC, Malapert G, Petrosyan A, Pujos C, Jazayeri S, Bouchot O. Comparison of automated fastener device Cor-Knot versus manually-tied knot in minimally-invasive isolated aortic valve replacement surgery. J Cardiovasc Surg (Torino). 2020 Feb;61(1):123-128. doi: 10.23736/S0021-9509.19.10792-6. Epub 2019 Oct 4.

Reference Type RESULT
PMID: 31599141 (View on PubMed)

Other Identifiers

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MORGANT 2018

Identifier Type: -

Identifier Source: org_study_id

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