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

Phase 2

Suspended

• Conditions: Mitral Regurgitation; Heart Failure
• Interventions: Device: Percutaneous transvenous mitral annuloplasty

• Registration Number: NCT00815386
• Lead Sponsor: Viacor

Brief 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.

Study Timeline

• Study First Submitted: 2008-12-26
• Study First Submitted QC: 2008-12-26
• Study First Posted: 2008-12-30
• Study Start: 2009-02
• Primary Completion: 2010-12
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-14
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PTMA implanted	Percutaneous transvenous mitral annuloplasty	Enrolled patients receiving a PTMA implant

Primary Outcome Measures

Name	Time	Method
Reduction of mitral regurgitation	6 months
Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke).	30 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Laval Hospital, Quebec Heart-Lung Institute; 🇨🇦 Quebec City, Quebec, Canada

Royal Victoria Hospital, McGill University Medical Center; 🇨🇦 Montreal, Quebec, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada