Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System (AcChord)

NeoChord

Status: Enrolling

Conditions: Heart Valve Diseases; Mitral Valve Disease; Mitral Valve Insufficiency; Mitral Regurgitation; Mitral Valve Prolapse

Treatments: Device: NeoChord Artificial Chordae Delivery System, Model DS1000

Study type: Observational

Funder types: Industry

Identifiers

NCT04190602

PR-610414-101

Details and patient eligibility

About

The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.

Full description

This study is an observational, single-arm, multicenter post-market registry. Both prospective and retrospective enrollment will be allowed. No additional invasive or burdensome examinations outside those routinely required for the standard mitral valve repair procedure will be requested.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
• Study procedure completed after 31 December 2016

Exclusion criteria

• Heavily calcified valves
• Valvular retraction with severely reduced mobility
• Active bacterial endocarditis
• Complex mechanism of MR (leaflet perforation, etc.)
• Significant tethering of leaflets
• Inflammatory valve disease