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Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTMA Implant | Device | Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein. |
|
| Measure | Description | Time Frame |
|---|---|---|
| percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension | 30 days | |
| improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainer Hoffmann, MD | Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen | Aachen | D-52057 | Germany |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006349 | Heart Valve Diseases |
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| 30 days |