Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients

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.

Official Title
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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

Conditions
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Heart Failure, Mitral Regurgitation

Intervention / Treatment
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* Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant


Participation Criteria
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Eligibility Criteria
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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

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: 1<br>Patient is screened for study and given baseline assessments. Pending fulfillment of study eligibility criteria, patient is implanted with PTMA system. | Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant<br>* Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein, anterior interventricular vein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from MACE at 30 days post-procedure and quantitative MR reduction at 6 months |  | 30 days to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of patients experiencing procedure or device-related adverse events |  | 30 days to 6 months | 
| 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 |  | 6 months | 
| Clinical status: % of treated patients exhibiting improvements in defined QoL parameters |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Mitral Regurgitation, Percutaneous, Coronary sinus