NCT00815386

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

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

• Status: Suspended
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Viacor · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Mitral Regurgitation
• Heart Failure

Interventions

Type	Name	Description
DEVICE	Percutaneous transvenous mitral annuloplasty	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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2010-12-01
• Completion: 2015-12-01
• First posted: 2008-12-30
• Last updated: 2011-02-14

Locations

3 sites across 1 country: Canada