NCT03681834

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
557

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2021

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

August 28, 2018

Last Update Submit

February 2, 2026

Conditions

Vascular Surgery

Outcome Measures

Primary Outcomes (1)

  • Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no )

    Day 30

Interventions

Data collectionOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring valve surgery

You may qualify if:

  • programmed minimally invasive surgery for:
  • aortic valve replacement
  • mitral valve replacement
  • mitral valve plastic surgery
  • adult patient

You may not qualify if:

  • emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

Related Publications (1)

  • 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.

    PMID: 31599141RESULT

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

September 24, 2018

Study Start

July 13, 2018

Primary Completion

March 25, 2021

Study Completion

March 25, 2021

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

FR(1)