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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572091
First Posted: December 12, 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
December 10, 2007
December 12, 2007
November 6, 2008
February 2007
April 2008   (Final data collection date for primary outcome measure)
percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery [ Time Frame: 30 days ]
Same as current
Complete list of historical versions of study NCT00572091 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Heart Failure
  • Mitral Regurgitation
Device: PTMA Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.
Experimental: 1
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Intervention: Device: PTMA Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
November 2008
April 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • MR of organic origins
  • significant co-morbidities
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00572091
06-055P
Yes
Not Provided
Not Provided
Katharine M Stohlman, Viacor, Inc.
Viacor
Not Provided
Principal Investigator: Rainer Hoffmann, MD Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
Viacor
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP