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Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device (PTOLEMY)

This study has been completed.
Information provided by:
Viacor Identifier:
First received: November 30, 2007
Last updated: November 5, 2008
Last verified: November 2008
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

Condition Intervention Phase
Heart Failure Mitral Regurgitation Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.

Further study details as provided by Viacor:

Primary Outcome Measures:
  • percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • percent of implanted patients who maintain a sustained 1 grade reduction in MR and reduction of mitral annulus anterior posterior dimension [ Time Frame: 30 days ]
  • percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max [ Time Frame: 30 days ]

Enrollment: 5
Study Start Date: April 2006
Study Completion Date: November 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Device: PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Functional MR 2+ - 4+ with left ventricular enlargement
  • Symptomatic heart failure
  • 20% - 50% LVEF

Exclusion Criteria:

  • mitral regurgitation of organic origins
  • recent cardiac interventions
  • severe comorbidities
  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 identifier: NCT00571610

Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Principal Investigator: Luc Bilodeau, MD Montreal Heart Institute
  More Information

Additional Information:
Responsible Party: Katharine M Stohlman, Viacor, Inc. Identifier: NCT00571610     History of Changes
Other Study ID Numbers: 05-020P
Study First Received: November 30, 2007
Last Updated: November 5, 2008

Keywords provided by Viacor:
Heart Failure
Mitral Regurgitation

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases processed this record on September 21, 2017