Multi-center Register for the Use of the Cor-Knot® Automa... | NCT03681834

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

NCT03681834

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 4, 2026Actual

Enrollment

557Actual

Phase

Not provided

Conditions

Vascular Surgery

Interventions

Data collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 13, 2018Actual

Primary Completion Date

Mar 25, 2021Actual

Completion Date

Mar 25, 2021Actual

First Submitted Date

Aug 28, 2018

First Submission Date that Met QC Criteria

Sep 20, 2018

First Posted Date

Sep 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

557Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection	Other	Data on the effectiveness and safety of the Cor-Knot® knotting device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Presence of periprosthetic leak around the prosthetic rings as determined during physical examination (rated yes/no )		Day 30

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

emergency surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients requiring valve surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourogne		Dijon		21000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31599141	Result	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.

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care