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

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ClinicalTrials.gov Identifier: NCT00572091
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : November 6, 2008
Sponsor:
Information provided by:
Viacor

Brief Summary:
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device

Condition or disease Intervention/treatment Phase
Heart Failure Mitral Regurgitation Device: PTMA Implant Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation
Study Start Date : February 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

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

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 Implant
Percutaneous assessment from right or left subclavian vein, with 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 mitral regurgitation and reduction in mitral anterior posterior dimension [ Time Frame: 30 days ]
  2. improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max. [ Time Frame: 30 days ]


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

Inclusion Criteria:

  • Symptomatic heart failure
  • functional MR 2+ - 4+
  • LVEF 20% - 50%

Exclusion Criteria:

  • MR of organic origins
  • significant co-morbidities

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): NCT00572091


Locations
Germany
Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
Aachen, Germany, D-52057
Sponsors and Collaborators
Viacor
Investigators
Principal Investigator: Rainer Hoffmann, MD Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Additional Information:
Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00572091     History of Changes
Other Study ID Numbers: 06-055P
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