An observational study in Mitral Regurgitation, Mitral Valve Disease and Mitral Valve Insufficiency, sponsored by NeoChord. Recruiting at 5 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-10.
Sponsored by NeoChord · Observational
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.
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.
459 studies on the registry are indexed under Mitral Valve Insufficiency; 148 are open to participants now.
This study's planned enrollment of 500 is above the median of 154 across 167 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →NeoChord is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients who meet the indications and are not contraindicated for treatment by the NeoChord Artificial Chordae Delivery System, Model DS1000.
Exclusion Criteria:
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.
Also known as: NeoChord DS1000, DS1000
Level of Mitral Regurgitation Following the Index Procedure
Level of mitral regurgitation per echocardiography
Time frame: Completion of Index Procedure
Level of Mitral Regurgitation at 3-6 Months
Level of mitral regurgitation per echocardiography
Time frame: 3-6 Months
Level of Mitral Regurgitation at 1 Year
Level of mitral regurgitation per echocardiography
Time frame: 1 Year
Level of Mitral Regurgitation at 2 Years
Level of mitral regurgitation per echocardiography
Time frame: 2 Years
Level of Mitral Regurgitation at 3 Years
Level of mitral regurgitation per echocardiography
Time frame: 3 Years
Level of Mitral Regurgitation at 4 Years
Level of mitral regurgitation per echocardiography
Time frame: 4 Years
Level of Mitral Regurgitation at 5 Years
Level of mitral regurgitation per echocardiography
Time frame: 5 Years
Freedom from Mitral Valve Re-intervention
Time frame: From enrollment until date of mitral valve reintervention, up to 5 years
Freedom from All-Cause Mortality
Time frame: From enrollment until date of death, up to 5 years
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
NeoChord