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

This study has suspended participant recruitment.
(Company ended operations in January 2011)
Sponsor:
Collaborators:
Duke University
Medifacts International Corporation
Information provided by:
Viacor
ClinicalTrials.gov Identifier:
NCT00815386
First received: December 26, 2008
Last updated: February 10, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Mitral Regurgitation
Heart Failure
Device: Percutaneous transvenous mitral annuloplasty
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Viacor:

Primary Outcome Measures:
  • Reduction of mitral regurgitation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Freedom from major adverse cardiac events (death, MI, emergent cardiac surgery, and stroke). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of 6 minute walk distance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement in Quality of Life Score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction of mitral regurgitation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Freedom from procedure-related or device-related major adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00815386

Locations
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
Viacor
Duke University
Medifacts International Corporation
Investigators
Principal Investigator: Luc Bilodeau, MD Montreal Heart Institute
  More Information

Additional Information:
Publications:

Responsible Party: Katharine M Stohlman, VP Regulatory Affairs, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00815386     History of Changes
Other Study ID Numbers: 08-037P
Study First Received: December 26, 2008
Last Updated: February 10, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on October 19, 2014