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

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ClinicalTrials.gov Identifier: NCT00571610
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : November 6, 2008
Sponsor:
Information provided by:
Viacor

Brief Summary:
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
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.
Study Start Date : April 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : November 2008

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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

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

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 ClinicalTrials.gov identifier (NCT number): NCT00571610


Locations
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Viacor
Investigators
Principal Investigator: Luc Bilodeau, MD Montreal Heart Institute

Additional Information:
Publications:
Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00571610     History of Changes
Other Study ID Numbers: 05-020P
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: November 6, 2008
Last Verified: November 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