Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The AcChord Study: A Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
NeoChord
500 participants
Feb 9, 2020
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
- Study procedure completed after 31 December 2016
Exclusion Criteria6
- 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
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Interventions
The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04190602