Dynamic Annuloplasty System With Activation for the Treatment of Mitral Regurgitation
NCT ID: NCT00833014
Last Updated: 2009-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
130 participants
INTERVENTIONAL
2008-12-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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I
Dynamic Annuloplasty Ring (with option to adjust off-pump)
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.
Interventions
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Dynamic Annuloplasty Ring (with option to adjust off-pump)
Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant.
Eligibility Criteria
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Inclusion Criteria
2. This patient has been diagnosed with a diseased natural valve, based on echocardiography and is a candidate for mitral valve repair.
3. This patient is in satisfactory condition, based on the physical exam and investigator's experience, to be an average or better operative risk. (i.e., likely to survive one year postoperatively).
4. This patient is geographically stable and willing to return to the implant center for follow-up visits.
5. This patient has been adequately informed of his/her participation in the clinical study, and of what will be required of him/her, in order to comply with the protocol.
Exclusion Criteria
2. This patient has a non-cardiac major or progressive disease, which in the investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than twelve months.
3. This patient has an ejection fraction \< 30%.
4. This patient has a heavily calcified annulus or leaflets.
5. This patient presents with active endocarditis or has had active endocarditis in the last 3 months.
6. This patient is pregnant (urine HCG test result positive) or lactating.
7. This patient is an intravenous drug abuser or alcohol abuser.
8. This patient has a previously implanted prosthetic mitral valve.
9. This patient requires mitral valve replacement.
10. This patient has a creatinine level \> 2.0 mg/dl
11. This patient has had congestive heart failure within the past 6 months requiring surgical treatment.
12. This patient has had a coronary artery ischemic event within the past 6 months.
13. This patient has a known life threatening, non-cardiac disease that will limit the patient's life expectancy to less than one year.
14. This patient is unable to take Coumadin.
15. This patient has a known untreatable allergy to contrast media or nickel.
16. This patient has had a cerebral vascular event within the past 6 months.
17. This patient is a prisoner (U.S.A. Only).
18. This patient is participating in concomitant research studies of investigational products.
19. This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up.
18 Years
ALL
No
Sponsors
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MiCardia Corporation
INDUSTRY
Responsible Party
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MiCardia Corporation
Locations
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University of British Columbia
Vancouver, British Columbia, Canada
University of Saarlands
Homburg, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
University of Leipzig Herzzentrum
Leipzig, , Germany
Erasmus MC
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Kevin Schillitto
Role: primary
Frank Langer, MD
Role: primary
Arne M Eide, MD
Role: primary
Sissy Ott
Role: primary
Liesbeth Duininck
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Bolling SF. Mitral reconstruction in cardiomyopathy. J Heart Valve Dis. 2002 Jan;11 Suppl 1:S26-31.
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.
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.
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.
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.
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.
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.
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.
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.
Tanemoto K. Surgical treatment of ischemic mitral valve regurgitation. Ann Thorac Cardiovasc Surg. 2005 Aug;11(4):228-31.
Le HC, Thys DM. Ischemic mitral regurgitation. Semin Cardiothorac Vasc Anesth. 2006 Mar;10(1):73-7. doi: 10.1177/108925320601000113.
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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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TP07-006
Identifier Type: -
Identifier Source: org_study_id