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

Recruiting now

Conditions studied: Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse, Heart Valve Diseases

In brief

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.

Key facts

Study ID

NCT04190602

Run by

NeoChord

People needed

500

Starts

2020-02-09

Expected to finish

2027-12-01

Last updated by the study team

2020-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Bonn — Bonn, Germany (enrolling)
• CVC Frankfurt — Frankfurt, Germany (enrolling)
• University of Mainz — Mainz, Germany (enrolling)
• Hippokration Hospital — Athens, Greece (enrolling)
• Triemli Hospital — Zurich, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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