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. - Ptolemy-2

Viacor Inc.0 sites14 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

Viacor Inc.

•1\. Patient has moderate functional MR: regurgitant orifice area \>/\= 0\.20cm2 or regurgitant volume \>/\= 30 mL/beat or regurgitant fraction \>/\= 30%.
•2\. Symptomatic heart failure NYHA Class II to IV
•3\. LV dysfunction (25% \< LVEF \< 50% by echocardiography)
•4\. Age \>/\= 50 Years.
•5\. Patient has signed the informed consent agreement.

•Exclusion Criteria
•1\. Mitral regurgitation of organic origin such as: degenerative disease (prolapse), rheumatic disease (commissural fusion, shortening and thickening of the subvalvular apparatus), endocarditis, flail segments, congenital mitral disease, significant annular calcification, significant pathology of the chords.
•2\. Severe mitral leaflet tethering.
•3\. Valvular apparatus cannot be visualized by 2D transthoracic echo. Valvular regurgitation cannot be quantified by 2D echo PISA or Doppler techniques.
•4\. Serious allergy to intravenous contrast agents or serious renal dysfunction (glomerular filtration rate less than 30 ccs/minute, as calculated by the Cockroft\-Gult equation), or otherwise major contra\-indication for contrast angiography.
•5\. History of myocardial infarct (MI) within 60 days prior to study procedure.
•6\. History of PCI within 60 days prior to study procedure.
•7\. Patient is not capable of walking 100 meters in 6 minutes.
•8\. Patient cannot complete the QOL survey with a meaningful score.
•9\. Indication of left\-dominant coronary circulation with angiography.

Not specified