Status:
SUSPENDED
Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Lead Sponsor:
Viacor
Collaborating Sponsors:
Duke University
Medifacts International Corporation
Conditions:
Mitral Regurgitation
Heart Failure
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus
Detailed Description
Device under Test: The Viacor® Percutaneous Transvenous Mitral Annuloplasty (PTMA) system comprises a sterile implantable cardiac device and associated custom accessories to assist implantation. The P...
Eligibility Criteria
Inclusion
- Patient has moderate functional MR: regurgitant orifice area \>/= 0.20cm2 or regurgitant volume \>/= 30 mL/beat or regurgitant fraction \>/= 30%
- Symptomatic heart failure NYHA Class II to IV
- LV dysfunction (25% \< LVEF \< 50% by echocardiography) 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 :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00815386
Start Date
February 1 2009
End Date
December 1 2015
Last Update
February 14 2011
Active Locations (3)
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1
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
2
Royal Victoria Hospital, McGill University Medical Center
Montreal, Quebec, Canada, H3A1A1
3
Laval Hospital, Quebec Heart-Lung Institute
Québec, Quebec, Canada, G1V4G5