Back to resultsAachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation (PTOLEMY)
Primary Purpose
Heart Failure, Mitral Regurgitation
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
PTMA Implant
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Mitral Regurgitation
Eligibility Criteria
Inclusion Criteria:
- Symptomatic heart failure
- functional MR 2+ - 4+
- LVEF 20% - 50%
Exclusion Criteria:
- MR of organic origins
- significant co-morbidities
Sites / Locations
- Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Outcomes
Primary Outcome Measures
percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery
Secondary Outcome Measures
percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00572091
Brief Title
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Acronym
PTOLEMY
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 Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Viacor
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mitral Regurgitation
Keywords
Heart Failure, Mitral Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Intervention Type
Device
Intervention Name(s)
PTMA Implant
Intervention Description
Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic heart failure
functional MR 2+ - 4+
LVEF 20% - 50%
Exclusion Criteria:
MR of organic origins
significant co-morbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Hoffmann, MD
Organizational Affiliation
Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen
City
Aachen
ZIP/Postal Code
D-52057
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
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