Heart Valve Diseases, Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse
Conditions
Keywords
NeoChord, DS1000, Artificial Chordae, Mitral Valve Repair
Brief 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.
Detailed description
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.
Interventions
DEVICENeoChord Artificial Chordae Delivery System, Model DS1000
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.
Sponsors
NeoChord
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Level of Mitral Regurgitation Following the Index Procedure | Completion of Index Procedure | Level of mitral regurgitation per echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of Mitral Regurgitation at 3-6 Months | 3-6 Months | Level of mitral regurgitation per echocardiography |
| Level of Mitral Regurgitation at 1 Year | 1 Year | Level of mitral regurgitation per echocardiography |
| Level of Mitral Regurgitation at 2 Years | 2 Years | Level of mitral regurgitation per echocardiography |
| Level of Mitral Regurgitation at 4 Years | 4 Years | Level of mitral regurgitation per echocardiography |
| Level of Mitral Regurgitation at 5 Years | 5 Years | Level of mitral regurgitation per echocardiography |
| Level of Mitral Regurgitation at 3 Years | 3 Years | Level of mitral regurgitation per echocardiography |
Other
| Measure | Time frame |
|---|---|
| Freedom from Mitral Valve Re-intervention | From enrollment until date of mitral valve reintervention, up to 5 years |
| Freedom from All-Cause Mortality | From enrollment until date of death, up to 5 years |
Countries
Germany, Greece, Switzerland
Contacts
Primary ContactAlexandar Jonkers
Outcome results
None listed