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Study to evaluate the safety and performance of the INNOVALVE system
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | MV replacement with INNOVALVE system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INNOVALVE system | Device | INNOVALVE system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of implant or delivery related serious adverse events at 30 Days | Absence of implant or delivery related serious adverse events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Procedure | |
| Procedural success | 30 days | |
| NYHA functional class |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TMTT Clinical | Contact | (949) 250-2500 | TMTT_Clinical@edwards.com |
| Name | Affiliation | Role |
|---|---|---|
| Chet Rihal | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai | Recruiting | Los Angeles | California | 90048 | United States |
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| 30 days, 6, 12 months and annually up to 5 years |
| Six-minute walk test | 30 days, 6, 12 months and annually up to 5 years |
| Quality of life improvement (KCCQ-12) | 30 days, 6, 12 months and annually up to 5 years |
| Reduction in MR grade | 30 days, 6, 12 months and annually up to 5 years |
| Stanford University | Recruiting | Palo Alto | California | 94305 | United States |
|
| Naples Comprehensive Health | Recruiting | Naples | Florida | 34102 | United States |
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| Emory University | Recruiting | Atlanta | Georgia | 30308 | United States |
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| Piedmont Heart Institute | Recruiting | Atlanta | Georgia | 30309 | United States |
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| Northwestern | Recruiting | Chicago | Illinois | 60611 | United States |
|
| University of Michigan Hospital and Health Systems | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Mayo Clinic | Recruiting | Rochester | Minnesota | 555905 | United States |
|
| Saint Luke's Hospital | Recruiting | Kansas City | Missouri | 64111 | United States |
|
| Morristown Medical Center | Recruiting | Morristown | New Jersey | 07960 | United States |
|
| Northwell Health | Recruiting | Manhasset | New York | 11030 | United States |
|
| Cornell | Withdrawn | New York | New York | 10021 | United States |
| NewYork-Presbyterian / Columbia University | Recruiting | New York | New York | 10032 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| OhioHealth Research Institute | Recruiting | Columbus | Ohio | 43214 | United States |
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| Oregon Health & Science Universtiy | Recruiting | Portland | Oregon | 97239 | United States |
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| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Ascension Saint Thomas | Recruiting | Nashville | Tennessee | 37205 | United States |
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| Swedish Medical Center | Recruiting | Seattle | Washington | 98122 | United States |
|
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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