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

Vascular Surgery Clinical Trial

— RECORVA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03681834
• Other study ID #: MORGANT 2018
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: December 2020

Study information

• Verified date: September 2018
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Marie-Catherine MORGANT
• Phone: +33 380293352
• Email: mariecatherine.morgant[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 364
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• programmed minimally invasive surgery for:

• aortic valve replacement

• mitral valve replacement

• mitral valve plastic surgery

• adult patient

Exclusion Criteria:

• emergency surgery

Related Conditions & MeSH terms

• Vascular Surgery

Intervention

Other:
• Data collection
Data on the effectiveness and safety of the Cor-Knot® knotting device

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

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