Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure (PTOLEMY2Canada)

Viacor

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Mitral Regurgitation; Heart Failure

Treatments: Device: Percutaneous transvenous mitral annuloplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00815386

08-037P

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

PTMA implanted

Experimental group

Description:

Enrolled patients receiving a PTMA implant

Treatment:

Device: Percutaneous transvenous mitral annuloplasty