Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
NCT ID: NCT00787293
Last Updated: 2011-02-14
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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SUSPENDED
PHASE2
30 participants
INTERVENTIONAL
2008-10-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system.
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.
Interventions
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PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.
Eligibility Criteria
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Inclusion Criteria
* Symptomatic heart failure, NYHA Class II to IV
* LVEF \> 25% or \< 50% OR dilated mitral annulus \> 30mm
Exclusion Criteria
* Severe mitral leaflet tethering
* History of MI or PCI within 60 days of study procedure
* Inability to walk a minimum of 100 meters in 6 minutes
* Significant left main stenosis or proximal circumflex stent
* Indication of non-patent CSO or discontinuous CS-GCV-AIV
* Bi-ventricular with leads in CS or other devices impeding device placement
* Severe aortic valvular disease
* Chronic corticosteroid use other than \< 20mg prednisone for arthritis
* Significant co-morbidities
50 Years
ALL
No
Sponsors
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Duke University
OTHER
Medifacts International Corporation
INDUSTRY
Viacor
INDUSTRY
Responsible Party
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Viacor, Inc.
Principal Investigators
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Stefan Sack, Md, PhD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH
Rainer Hoffmann, MD
Role: PRINCIPAL_INVESTIGATOR
R-WTH Universitätsklinikum Aachen
Locations
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Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
Aalst, , Belgium
Centre Hospitalier Universitaire de Liège
Liège, , Belgium
Institut Klinicke a Experimentalni Mediciny
Prague, , Czechia
Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
Aachen, , Germany
Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum
Bad Oeynhausen, , Germany
Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen
Essen, , Germany
CardioVascular Center Frankfurt Sankt Katharinen
Frankfurt, , Germany
Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Städtische Klinikum Karlsruhe GmbH
Karlsruhe, , Germany
Klinikum Schwabing Städtisches Klinikum München GmbH
München, , Germany
Thoraxcentrum Erasmus Medisch Centrum
Rotterdam, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Hôpital Universitaire de Genève
Geneva, , Switzerland
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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08-010P
Identifier Type: -
Identifier Source: org_study_id
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