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

RECRUITINGSponsored by NeoChord
Actively Recruiting
SponsorNeoChord
Started2020-02-09
Est. completion2022-10
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04190602

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions6

Heart DiseaseHeart Valve DiseasesMitral RegurgitationMitral Valve DiseaseMitral Valve InsufficiencyMitral Valve Prolapse

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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