About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Has Grade III Moderate or Grade IV Severe degenerative or mixed disease mitral valve regurgitation
Study procedure completed after 31 December 2016
Disqualifiers
Heavily calcified valves
Valvular retraction with severely reduced mobility
Active bacterial endocarditis
Complex mechanism of MR (leaflet perforation, etc.)
Trial population
Adult patients who meet the indications and are not contraindicated for treatment by the NeoChord Artificial Chordae Delivery System, Model DS1000.
Trial design
Cohort
Other
Treatments tested in this trial
NeoChord Artificial Chordae Delivery System, Model DS1000
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Level of Mitral Regurgitation Following the Index Procedure
Level of mitral regurgitation per echocardiography
Secondary outcomes
Level of Mitral Regurgitation at 3-6 Months
Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 1 Year
Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 2 Years
Level of mitral regurgitation per echocardiography
Level of Mitral Regurgitation at 3 Years
Level of mitral regurgitation per echocardiography
Other outcomes
Freedom from Mitral Valve Re-intervention
Freedom from All-Cause Mortality