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The objective of this trial is to assess the safety and effectiveness of the study device in subjects with degenerative mitral valve disease receiving a mitral valve repair without cardiopulmonary bypass (treatment group) when compared to subjects receiving mitral valve repair using standard surgical techniques with cardiopulmonary bypass (control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Subjects with degenerative mitral valve insufficiency treated with artificial chordae implanted using the NeoChord DS1000 |
|
| Control Group | Active Comparator | Subjects with degenerative mitral valve insufficiency treated with standard surgical mitral valve repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoChord DS1000 | Device | Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects free of Major Adverse Events (MAEs) in the treatment group when compared to subjects in the control group. | Post-operative Day (POD) 30 | |
| Proportion of subjects free of Grade II, III or IV mitral regurgitation, mitral valve replacement or mitral valve reintervention in the treatment group when compared to subjects in the control group. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy General Hospital | Sacramento | California | 95819 | United States | ||
| Stanford University |
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| Surgical Mitral Valve Repair | Device | Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae. |
|
| Stanford |
| California |
| 94305 |
| United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Piedmont Heart Institute | Atlanta | Georgia | 30339 | United States |
| Franciscan Health | Indianapolis | Indiana | 46237 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Mount Sinai, Icahn School of Medicine | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Pinnacle Health | Harrisburg | Pennsylvania | 17110 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15232 | United States |
| St. Thomas | Nashville | Tennessee | 37205 | United States |
| Baylor - Plano | Plano | Texas | 75093 | United States |
| Valley Health System | Virginia | Winchester | Virginia | 22601 | United States |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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