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
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: 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 September 16, 2014