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The device is a dynamic annuloplasty ring/band that is able to be adjusted in order to correct for mitral regurgitation intraoperatively or postoperatively, off-pump.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Annuloplasty Ring (with option to adjust off-pump) | Device | Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major complications and SAM (Systolic Anterior Motion) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to adjust annuloplasty ring off-pump post implantation to correct for residual regurgitation, reduction of mitral valve regurgitation at follow-up visits (discharge, 30 days, 6 months) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jody L Errandi, M.S. | Contact | 949.951.4888 | 12 | jerrandi@micardia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Not yet recruiting | Vancouver | British Columbia | V6Z1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18843917 | Background | Baev B, Petkov D, Iliev R, Nachev G. [Mitral valve repair for mitral regurgitation--15 year results]. Khirurgiia (Sofiia). 2006;(4-5):19-22. Bulgarian. | |
| 225223 | Background | Manesis EK, Cameron CH, Gregoriadis G. Hepatitis-B-surface-antigen-containing liposomes enhance humoral and cell-mediated immunity to the antigen [proceedings]. Biochem Soc Trans. 1979 Aug;7(4):678-80. doi: 10.1042/bst0070678. No abstract available. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| University of Saarlands | Recruiting | Homburg | 66421 | Germany |
|
| Universitatsklinikum Schleswig-Holstein | Recruiting | Kiel | 24105 | Germany |
|
| University of Leipzig Herzzentrum | Recruiting | Leipzig | 04289 | Germany |
|
| Erasmus MC | Not yet recruiting | Rotterdam | Netherlands |
|
| 15573077 | Background | McGee EC, Gillinov AM, Blackstone EH, Rajeswaran J, Cohen G, Najam F, Shiota T, Sabik JF, Lytle BW, McCarthy PM, Cosgrove DM. Recurrent mitral regurgitation after annuloplasty for functional ischemic mitral regurgitation. J Thorac Cardiovasc Surg. 2004 Dec;128(6):916-24. doi: 10.1016/j.jtcvs.2004.07.037. |
| 14759429 | Background | Sharony R, Saunders PC, Nayar A, McAleer E, Galloway AC, Delianides J, Schwartz CF, Applebaum RM, Kronzon I, Colvin SB, Grossi EA. Semirigid partial annuloplasty band allows dynamic mitral annular motion and minimizes valvular gradients: an echocardiographic study. Ann Thorac Surg. 2004 Feb;77(2):518-22; discussion 522. doi: 10.1016/j.athoracsur.2003.06.005. |
| 19099047 | Background | Hashim SW, Rousou AJ, Geirsson A, Ragnarsson S. Solving the puzzle of chronic ischemic mitral regurgitation. Yale J Biol Med. 2008 Dec;81(4):167-73. |
| 19032915 | Background | Leacche M, Balaguer JM, Byrne JG. Role of cardiac surgery in the post-myocardial infarction patient with heart failure. Curr Heart Fail Rep. 2008 Dec;5(4):204-10. doi: 10.1007/s11897-008-0031-z. |
| 17723937 | Background | Spoor MT, Bolling SF. Valve pathology in heart failure: which valves can be fixed? Heart Fail Clin. 2007 Jul;3(3):289-98. doi: 10.1016/j.hfc.2007.04.008. |
| 11843517 | Background | Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31. |
| 19075105 | Background | Lloyd-Jones D, Adams R, Carnethon M, De Simone G, Ferguson TB, Flegal K, Ford E, Furie K, Go A, Greenlund K, Haase N, Hailpern S, Ho M, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott M, Meigs J, Mozaffarian D, Nichol G, O'Donnell C, Roger V, Rosamond W, Sacco R, Sorlie P, Stafford R, Steinberger J, Thom T, Wasserthiel-Smoller S, Wong N, Wylie-Rosett J, Hong Y; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009 Jan 27;119(3):e21-181. doi: 10.1161/CIRCULATIONAHA.108.191261. Epub 2008 Dec 15. No abstract available. |
| 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. |
| 15655133 | Background | Bursi F, Enriquez-Sarano M, Nkomo VT, Jacobsen SJ, Weston SA, Meverden RA, Roger VL. Heart failure and death after myocardial infarction in the community: the emerging role of mitral regurgitation. Circulation. 2005 Jan 25;111(3):295-301. doi: 10.1161/01.CIR.0000151097.30779.04. Epub 2005 Jan 17. |
| 11988951 | Background | Badhwar V, Bolling SF. Mitral valve surgery in the patient with left ventricular dysfunction. Semin Thorac Cardiovasc Surg. 2002 Apr;14(2):133-6. doi: 10.1053/stcs.2002.32314. |
| 2138525 | Background | Pfeffer MA, Braunwald E. Ventricular remodeling after myocardial infarction. Experimental observations and clinical implications. Circulation. 1990 Apr;81(4):1161-72. doi: 10.1161/01.cir.81.4.1161. |
| 15785176 | Background | Gillinov AM, Cosgrove DM 3rd. Current status of mitral valve repair. Am Heart Hosp J. 2003 Winter;1(1):47-54. doi: 10.1111/j.1541-9215.2003.02082.x. |
| 12970215 | Background | Moss RR, Humphries KH, Gao M, Thompson CR, Abel JG, Fradet G, Munt BI. Outcome of mitral valve repair or replacement: a comparison by propensity score analysis. Circulation. 2003 Sep 9;108 Suppl 1:II90-7. doi: 10.1161/01.cir.0000089182.44963.bb. |
| 8875918 | Background | Ling LH, Enriquez-Sarano M, Seward JB, Tajik AJ, Schaff HV, Bailey KR, Frye RL. Clinical outcome of mitral regurgitation due to flail leaflet. N Engl J Med. 1996 Nov 7;335(19):1417-23. doi: 10.1056/NEJM199611073351902. |
| 16148868 | Background | Tanemoto K. Surgical treatment of ischemic mitral valve regurgitation. Ann Thorac Cardiovasc Surg. 2005 Aug;11(4):228-31. |
| 16703238 | Background | Le HC, Thys DM. Ischemic mitral regurgitation. Semin Cardiothorac Vasc Anesth. 2006 Mar;10(1):73-7. doi: 10.1177/108925320601000113. |
| 10750749 | Background | Gillinov AM, Cosgrove DM 3rd, Shiota T, Qin J, Tsujino H, Stewart WJ, Thomas JD, Porqueddu M, White JA, Blackstone EH. Cosgrove-Edwards Annuloplasty System: midterm results. Ann Thorac Surg. 2000 Mar;69(3):717-21. doi: 10.1016/s0003-4975(99)01543-x. |
| 18319323 | Background | Chee T, Haston R, Togo A, Raja SG. Is a flexible mitral annuloplasty ring superior to a semi-rigid or rigid ring in terms of improvement in symptoms and survival? Interact Cardiovasc Thorac Surg. 2008 May;7(3):477-84. doi: 10.1510/icvts.2007.174243. Epub 2008 Mar 4. |
| 17561410 | Background | Meyer MA, von Segesser LK, Hurni M, Stumpe F, Eisa K, Ruchat P. Long-term outcome after mitral valve repair: a risk factor analysis. Eur J Cardiothorac Surg. 2007 Aug;32(2):301-7. doi: 10.1016/j.ejcts.2007.05.008. Epub 2007 Jun 11. |
| 17382640 | Background | Chang BC, Youn YN, Ha JW, Lim SH, Hong YS, Chung N. Long-term clinical results of mitral valvuloplasty using flexible and rigid rings: a prospective and randomized study. J Thorac Cardiovasc Surg. 2007 Apr;133(4):995-1003. doi: 10.1016/j.jtcvs.2006.10.023. Epub 2007 Feb 22. |
| 15470654 | Background | Staniloae C, Dupuis J, White M, Gosselin G, Dyrda I, Bois M, Crepeau J, Bonan R, Caron A, Lavoie J. Reduced pulmonary clearance of endothelin in congestive heart failure: a marker of secondary pulmonary hypertension. J Card Fail. 2004 Oct;10(5):427-32. doi: 10.1016/j.cardfail.2004.01.008. |