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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00815386
Recruitment Status : Suspended (Company ended operations in January 2011)
First Posted : December 30, 2008
Last Update Posted : February 14, 2011
Duke University
Medifacts International Corporation
Information provided by:

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

Condition or disease Intervention/treatment Phase
Mitral Regurgitation Heart Failure Device: Percutaneous transvenous mitral annuloplasty Phase 2 Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Percutaneous Transvenous Mitral Annuloplasty System to Reduce Mitral Valve Regurgitation in Patients With Heart Failure
Study Start Date : February 2009
Actual Primary Completion Date : December 2010
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PTMA implanted
Enrolled patients receiving a PTMA implant
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.
Other Names:
  • mitral annuloplasty
  • sinoplasty

Primary Outcome Measures :
  1. Reduction of mitral regurgitation [ Time Frame: 6 months ]
  2. Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke). [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Improvement of 6 minute walk distance [ Time Frame: 6 months ]
  2. Improvement in Quality of Life Score [ Time Frame: 6 months ]
  3. Reduction of mitral regurgitation [ Time Frame: 6 months ]
  4. Freedom from procedure-related or device-related major adverse events [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00815386

Canada, Ontario
University of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
Canada, Quebec
Royal Victoria Hospital, McGill University Medical Center
Montreal, Quebec, Canada, H3A1A1
Laval Hospital, Quebec Heart-Lung Institute
Quebec City, Quebec, Canada, G1V4G5
Sponsors and Collaborators
Duke University
Medifacts International Corporation
Principal Investigator: Luc Bilodeau, MD Montreal Heart Institute

Additional Information:

Responsible Party: Katharine M Stohlman, VP Regulatory Affairs, Viacor, Inc. Identifier: NCT00815386     History of Changes
Other Study ID Numbers: 08-037P
First Posted: December 30, 2008    Key Record Dates
Last Update Posted: February 14, 2011
Last Verified: February 2011

Keywords provided by Viacor:
mitral valve
heart failure
mitral regurgitation
coronary sinus

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases