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Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation (PTOLEMY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00568230
First Posted: December 5, 2007
Last Update Posted: November 6, 2008
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.
Information provided by:
Viacor
  Purpose
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.

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: An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.

Resource links provided by NLM:


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 mitral regurgitation and reduction of mitral annulus anterior posterior dimension [ Time Frame: 30 days ]
  • improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max [ Time Frame: 30 days ]

Enrollment: 12
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 with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • symptomatic heart failure
  • moderate to severe mitral regurgitation
  • 20 - 50% LVEF

Exclusion Criteria:

  • mitral regurgitation of organic origins
  • recent interventions
  • severe comorbidities
  Contacts and Locations
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): NCT00568230


Locations
Germany
Universitat Duisburg-Essen
Essen, Germany
Sponsors and Collaborators
Viacor
Investigators
Principal Investigator: Stefan Sack, MD Universitat Duisburg-Essen
  More Information

Additional Information:
Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00568230     History of Changes
Other Study ID Numbers: 05-023P
First Submitted: November 30, 2007
First Posted: December 5, 2007
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