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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoChord Artificial Chordae Delivery System, Model DS1000 | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of Mitral Regurgitation Following the Index Procedure | Level of mitral regurgitation per echocardiography | Completion of Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Mitral Regurgitation at 3-6 Months | Level of mitral regurgitation per echocardiography | 3-6 Months |
| Level of Mitral Regurgitation at 1 Year | Level of mitral regurgitation per echocardiography |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients who meet the indications and are not contraindicated for treatment by the NeoChord Artificial Chordae Delivery System, Model DS1000.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandar Jonkers | Contact | +31 610740977 | ajonkers@neochord.com |
| Name | Affiliation | Role |
|---|---|---|
| Andres Beiras Fernandez, MD PhD | Johannes Gutenberg University Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bonn | Recruiting | Bonn | Germany |
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| 1 Year |
| Level of Mitral Regurgitation at 2 Years | Level of mitral regurgitation per echocardiography | 2 Years |
| Level of Mitral Regurgitation at 3 Years | Level of mitral regurgitation per echocardiography | 3 Years |
| Level of Mitral Regurgitation at 4 Years | Level of mitral regurgitation per echocardiography | 4 Years |
| Level of Mitral Regurgitation at 5 Years | Level of mitral regurgitation per echocardiography | 5 Years |
| CVC Frankfurt | Recruiting | Frankfurt | Germany |
|
| University of Mainz | Recruiting | Mainz | Germany |
|
| Hippokration Hospital | Recruiting | Athens | Greece |
|
| Triemli Hospital | Recruiting | Zurich | Switzerland |
|
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D008945 | Mitral Valve Prolapse |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016127 | Heart Valve Prolapse |
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