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

This study has been completed.
Sponsor:
Information provided by:
Viacor
ClinicalTrials.gov Identifier:
NCT00571610
First received: November 30, 2007
Last updated: November 5, 2008
Last verified: November 2008
History of Changes
  Purpose

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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

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

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Sponsor Web Page (multi-lingual)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00571610     History of Changes
Other Study ID Numbers: 05-020P
Study First Received: November 30, 2007
Last Updated: November 5, 2008
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Viacor:
Heart Failure
Mitral Regurgitation

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

ClinicalTrials.gov processed this record on May 21, 2013