Aachen 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:
NCT00572091
First received: December 10, 2007
Last updated: November 5, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention Phase
Heart Failure
Mitral Regurgitation
Device: PTMA Implant
Phase 1
Phase 2

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 Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty 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 in mitral anterior posterior dimension [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: February 2007
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 Implant
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Katharine M Stohlman, Viacor, Inc.
ClinicalTrials.gov Identifier: NCT00572091     History of Changes
Other Study ID Numbers: 06-055P
Study First Received: December 10, 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 April 23, 2014