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

This study has been completed.
Sponsor:
Information provided by:
Viacor
ClinicalTrials.gov Identifier:
NCT00568230
First received: November 30, 2007
Last updated: November 5, 2008
Last verified: November 2008
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00568230     History of Changes
Other Study ID Numbers: 05-023P
Study First Received: November 30, 2007
Last Updated: November 5, 2008
Health Authority: Germany: Ethics Commission

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 September 16, 2014