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Company ended operations January 2011
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| Name | Class |
|---|---|
| Duke University | OTHER |
| Medifacts International Corporation | INDUSTRY |
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Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant | Device | Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months | 30 days to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| % of patients experiencing procedure or device-related adverse events | 30 days to 6 months | |
| Technical procedural success: % of patients maintaining a reduction of mitral annulus A/P dimension, sustained MR reduction, and decrease in left ventricular dimensions to specified degrees |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Sack, Md, PhD | Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH | Principal Investigator |
| Rainer Hoffmann, MD | R-WTH Universitätsklinikum Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst | Aalst | B-9300 | Belgium | |||
| Centre Hospitalier Universitaire de Liège |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18592924 | Background | Fukuda S, Gillinov AM, Liddicoat JR, Saracino G, Hayase M, Cohn WE, Schneider CW, Shiota T. Maintenance of geometric alterations associated with percutaneous mitral valve repair: real-time three-dimensional echocardiographic assessment in an ovine model. J Heart Valve Dis. 2008 May;17(3):276-82. | |
| 17400117 | Background |
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| 6 months |
| Clinical status: % of treated patients exhibiting improvements in defined QoL parameters | 6 months |
| Liège |
| B-4000 |
| Belgium |
| Institut Klinicke a Experimentalni Mediciny | Prague | 1958/9 | Czechia |
| Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen | Aachen | D-52074 | Germany |
| Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum | Bad Oeynhausen | D-32545 | Germany |
| Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen | Essen | D-45122 | Germany |
| CardioVascular Center Frankfurt Sankt Katharinen | Frankfurt | D-60389 | Germany |
| Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg | Freiburg im Breisgau | D-79095 | Germany |
| Städtische Klinikum Karlsruhe GmbH | Karlsruhe | D-76133 | Germany |
| Klinikum Schwabing Städtisches Klinikum München GmbH | München | D-80804 | Germany |
| Thoraxcentrum Erasmus Medisch Centrum | Rotterdam | N-3015 | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | N-3584 | Netherlands |
| Hôpital Universitaire de Genève | Geneva | 1211 | Switzerland |
| Daimon M, Gillinov AM, Liddicoat JR, Saracino G, Fukuda S, Koyama Y, Hayase M, Cohn WE, Ellis SG, Thomas JD, Shiota T. Dynamic change in mitral annular area and motion during percutaneous mitral annuloplasty for ischemic mitral regurgitation: preliminary animal study with real-time 3-dimensional echocardiography. J Am Soc Echocardiogr. 2007 Apr;20(4):381-8. doi: 10.1016/j.echo.2006.08.029. |
| 17525965 | Background | Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. doi: 10.1002/ccd.21186. |
| 15851597 | Background | Daimon M, Shiota T, Gillinov AM, Hayase M, Ruel M, Cohn WE, Blacker SJ, Liddicoat JR. Percutaneous mitral valve repair for chronic ischemic mitral regurgitation: a real-time three-dimensional echocardiographic study in an ovine model. Circulation. 2005 May 3;111(17):2183-9. doi: 10.1161/01.CIR.0000163547.03188.AC. Epub 2005 Apr 25. |
| 14571496 | Background | Liddicoat JR, Mac Neill BD, Gillinov AM, Cohn WE, Chin CH, Prado AD, Pandian NG, Oesterle SN. Percutaneous mitral valve repair: a feasibility study in an ovine model of acute ischemic mitral regurgitation. Catheter Cardiovasc Interv. 2003 Nov;60(3):410-6. doi: 10.1002/ccd.10662. |
| 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 |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |
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