Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Study Overview
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Brief Summary
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Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implantable device residing in the coronary sinus

Detailed Description
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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 PTMA system is intended to treat functional mitral regurgitation (MR) in a heart failure patient by a less invasive method than surgical annuloplasty with greater relief of symptoms than medical management alone. Study Objective: Functional mitral regurgitation is associated with an adverse prognosis in the heart failure patient. The objective of this study is to evaluate whether PTMA is effective in reducing mitral regurgitation in heart failure patients and whether this reduction is associated with a moderation in the adverse progression of heart failure symptoms. Hypothesis under Test: Reduction of the severity of functional mitral regurgitation from baseline, as defined by a composite improvement of quantitative echocardiographic metrics, can be achieved safely with the PTMA device and will be associated with a measurable moderation of adverse progression of heart failure symptoms and a moderation of the deterioration of exercise capacity.

Official Title
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Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure

Conditions
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Mitral Regurgitation, Heart Failure

Intervention / Treatment
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* Device: Percutaneous transvenous mitral annuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTMA implanted<br>Enrolled patients receiving a PTMA implant | Device: Percutaneous transvenous mitral annuloplasty<br>* Catheterization procedure with anesthesia requiring subclavicular puncture, catheterization of the right atrium and coronary sinus vein, placement and optimization of the PTMA device with access hub remaining subcutaneous at the clavicle.<br>* Other names: sinoplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of mitral regurgitation |  | 6 months | 
| Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke). |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of 6 minute walk distance |  | 6 months | 
| Improvement in Quality of Life Score |  | 6 months | 
| Reduction of mitral regurgitation |  | 6 months | 
| Freedom from procedure-related or device-related major adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mitral valve, heart failure, mitral regurgitation, annuloplasty, coronary sinus