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Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Treatment with the Edwards EVOQUE Eos mitral valve replacement system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edwards EVOQUE Eos Mitral Valve Replacement System | Device | Replacement of the mitral valve through a transcatheter approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of major adverse events | Proportion of patients with major adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA functional class | Number of patients with improvement in NYHA class | 30 days, 6 Months, 12 Months, annual for five years |
| Six minute walk test | Increase in distance (m) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajendra Makkar, MD | Cedars-Sinai Medical Center, Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sutter Mills-Peninsula | Burlingame | California | 94010 | United States | ||
| Cedars-Sinai Medical Center |
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| 30 days, 6 Months, 12 Months, annual for five years |
| Reduction in MR grade | Number of patients with reduction in MR grade from baseline | 30 days, 6 Months, 12 Months, annual for five years |
| Device Success | Proportion of patients with device deployed as intended and delivery system successfully retrieved | Immediately after procedure |
| Procedural Success | Proportion of patients with device success without significant paravalvular leak | Discharge or 7 days post-procedure, whichever occurs first |
| Clinical Success | Proportion of patients with procedural success without major adverse events | 30 days |
| Los Angeles |
| California |
| 90048 |
| United States |
| Kaiser Permanente San Francisco | San Francisco | California | 94118 | United States |
| Emory University Hospital/Emory University Hospital Midtown | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| St. Vincent Heart Center | Indianapolis | Indiana | 46260 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center | Houston | Texas | 77030 | United States |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | United States |
| Intermountain Medical Center | Murray | Utah | 84107 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| St. Paul's Hospital | Vancouver | British Columbia | Canada |
| Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval | Québec | G1V 4G5 | Canada |
| St. Michael's Hospital | Toronto | Canada |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D005764 | Gastroesophageal Reflux |
| D009362 | Neoplasm Metastasis |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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