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Improvement of 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 (Percutaneous Transvenous Mitral Annuloplasty) Implant | Device | Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket. |
| 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 of mitral annulus anterior posterior dimension | 30 days | |
| improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Sack, MD | Universitat Duisburg-Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Duisburg-Essen | Essen | 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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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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| 30 days |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |