Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
PTOLEMY
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.
1 other identifier
interventional
12
1 country
1
Brief Summary
Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 heart-failure
Started Apr 2006
Typical duration for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 30, 2007
CompletedFirst Posted
Study publicly available on registry
December 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedNovember 6, 2008
November 1, 2008
2 years
November 30, 2007
November 5, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
percent of patients who remain free from device-related major adverse events (death, myocardial infarction, tamponade, emergent cardiac surgery)
30 days
Secondary Outcomes (2)
percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction of mitral annulus anterior posterior dimension
30 days
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
30 days
Study Arms (1)
1
EXPERIMENTALPatient is screened for study, and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
Interventions
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.
Eligibility Criteria
You may qualify if:
- symptomatic heart failure
- moderate to severe mitral regurgitation
- % LVEF
You may not qualify if:
- mitral regurgitation of organic origins
- recent interventions
- severe comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viacorlead
Study Sites (1)
Universitat Duisburg-Essen
Essen, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Sack, MD
Universitat Duisburg-Essen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 30, 2007
First Posted
December 5, 2007
Study Start
April 1, 2006
Primary Completion
April 1, 2008
Study Completion
November 1, 2008
Last Updated
November 6, 2008
Record last verified: 2008-11