Back to resultsSafety 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 (Percutaneous Transvenous Mitral Annuloplasty) 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
- moderate to severe mitral regurgitation
- 20 - 50% LVEF
Exclusion Criteria:
- mitral regurgitation of organic origins
- recent interventions
- severe comorbidities
Sites / Locations
- Universitat Duisburg-Essen
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 of mitral annulus anterior posterior dimension
improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568230
Brief Title
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Acronym
PTOLEMY
Official Title
An Open-Label, Single-Arm Feasibility Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty (PTMA) Device Used to Reduce Mitral Regurgitation.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (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 of 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
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (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 (Percutaneous Transvenous Mitral Annuloplasty) Implant
Intervention Description
Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
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 of mitral annulus anterior posterior dimension
Time Frame
30 days
Title
improvement of clinical symptoms of heart failure as defined by percent of patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in exercise capacity: 6 minute walk or VO2max
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
symptomatic heart failure
moderate to severe mitral regurgitation
20 - 50% LVEF
Exclusion Criteria:
mitral regurgitation of organic origins
recent interventions
severe comorbidities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Sack, MD
Organizational Affiliation
Universitat Duisburg-Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Duisburg-Essen
City
Essen
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
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