Status:
SUSPENDED
Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients
Lead Sponsor:
Viacor
Collaborating Sponsors:
Duke University
Medifacts International Corporation
Conditions:
Heart Failure
Mitral Regurgitation
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device.
Eligibility Criteria
Inclusion
- Functional MR 2+ - 4+
- Symptomatic heart failure, NYHA Class II to IV
- LVEF \> 25% or \< 50% OR dilated mitral annulus \> 30mm
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00787293
Start Date
October 1 2008
End Date
November 1 2015
Last Update
February 14 2011
Active Locations (13)
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1
Onze Lieve Vrouw Ziekenhuis Cardiovasculair Ondrezoek Aalst
Aalst, Belgium, B-9300
2
Centre Hospitalier Universitaire de Liège
Liège, Belgium, B-4000
3
Institut Klinicke a Experimentalni Mediciny
Prague, Czechia, 1958/9
4
Rheinisch-Westfalische Technische Hochschule Universitaetsklinikum Aachen
Aachen, Germany, D-52074