Clinical trial NCT00787293: Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
Official title: A Multi-center Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Heart Failure
Mitral Regurgitation
Keywords: Heart Failure
Mitral Regurgitation
Percutaneous
Coronary sinus
Lead sponsor: Viacor
Sponsor class: INDUSTRY
Collaborators: name: Duke University
name: Medifacts International Corporation
First posted: 2008-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.


Eligibility criteria: Inclusion Criteria:

* Functional MR 2+ - 4+
* Symptomatic heart failure, NYHA Class II to IV
* LVEF \> 25% or \< 50% OR dilated mitral annulus \> 30mm

Exclusion Criteria:

* MR of organic origin
* 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

Primary outcomes:
measure: Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months
timeFrame: 30 days to 6 months
Secondary outcomes:
measure: % of patients experiencing procedure or device-related adverse events
timeFrame: 30 days to 6 months
measure: 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
timeFrame: 6 months
measure: Clinical status: % of treated patients exhibiting improvements in defined QoL parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
city: Liège
country: Belgium
facility: Centre Hospitalier Universitaire de Liège
city: Prague
country: Czech Republic
facility: Institut Klinicke a Experimentalni Mediciny
city: Aachen
country: Germany
facility: Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum Nordrhein-Westfalen / Ruhr University of Bochum
city: Essen
country: Germany
facility: Universitaet Duisburg-Essen Westdeutsches Herzzentrum Universitaetsklinikum Essen
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt Sankt Katharinen
city: Freiburg im Breisgau
country: Germany
facility: Albert-Ludwigs-Universitat Freiburg Mediziniche Universitätsklinikum Freiburg
city: Karlsruhe
country: Germany
facility: Städtische Klinikum Karlsruhe GmbH
city: München
country: Germany
facility: Klinikum Schwabing Städtisches Klinikum München GmbH
city: Rotterdam
country: Netherlands
facility: Thoraxcentrum Erasmus Medisch Centrum
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Geneva
country: Switzerland
facility: Hôpital Universitaire de Genève
Study officials:
affiliation: Klinikum Schwabing, Staedtisches Klinikum Muenchen GmbH
name: Stefan Sack, Md, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: R-WTH Universitätsklinikum Aachen
name: Rainer Hoffmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.