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Study has been terminated due to small sample size
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A prospective, open-label, and multi-centered feasibility registry.
This is a prospective, open-label, and multi-centered feasibility registry (single arm study). Approximately 36 subjects with prohibitive risk degenerative mitral regurgitation (DMR) who receive at least 1 commercial MitraClip will be registered at up to 10 US sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Commercial MitraClip® patients | Patients with Degenerative Mitral Regurgitation receiving MitraClip® Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention - registry | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observational change in daily reported activity levels (counts/min) as assessed by actigraphy, from baseline to 30 days post MitraClip implantation | Phillips Actiwatch Spectrum PRO is the device being used to capture the primary outcome measure | At 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of daily and weekly activity as assessed by actigraphy | Pre-procedure (on day 0) | |
| Levels of daily and weekly activity as assessed by actigraphy | Post-procedure (≤ 7 days) | |
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Inclusion Criteria:
Exclusion Criteria:
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Prohibitive risk degenerative mitral regurgitation (DMR) patients who receive at least 1 commercial MitraClip
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| Name | Affiliation | Role |
|---|---|---|
| Peter Staehr, MD | Abbott Medical Devices | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | 85006 | United States | ||
| Cedars-Sinai Medical Center |
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| Levels of daily and weekly activity as assessed by actigraphy |
| At 30 days |
| Levels of daily and weekly activity as assessed by actigraphy | At 2 months |
| Levels of daily and weekly activity as assessed by actigraphy | At 3 months |
| Levels of daily and weekly activity as assessed by actigraphy | At 4 months |
| Levels of daily and weekly activity as assessed by actigraphy | At 5 months |
| Patterns of daily Sleep/Wake by actigraphy | At 6 months |
| NYHA Functional Class | At Baseline |
| NYHA Functional Class | At 30 days |
| Mitral Regurgitation severity | At Baseline |
| Mitral Regurgitation severity | Post-procedure (≤ 7 days) |
| Mitral Regurgitation severity | At 30 days |
| Echocardiographic assessment | At Baseline |
| Echocardiographic assessment | Post-procedure (≤ 7 days) |
| Echocardiographic assessment | At 30 days |
| Distance walked 6 minute walk test (6MWT) | At Baseline |
| Distance walked 6 minute walk test (6MWT) | At 30 days |
| Health-related quality of life (QoL) | At Baseline |
| Health-related quality of life (QoL) | At 30 days |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Baptist Hospital of Miami | Miami | Florida | 33176 | United States |
| Mayo Foundation for Medical Education and Research | Rochester | Minnesota | 55905 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Bon Secours St Mary's Hospital | Richmond | Virginia | 23226 | United States |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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