Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
PTOLEMY
A Single-Center, Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Implantable Device Used to Reduce Mitral Valve Regurgitation.
1 other identifier
interventional
5
1 country
1
Brief Summary
Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.
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 12, 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 MR and reduction of mitral annulus anterior posterior dimension
30 days
percent of implanted patients who exhibit improvement of clinical symptoms as one of the following: decrease in NYHA class, improvement of Minnesota QOL survey, increase exercise capacity 6 minute walk or improvement in VO2 max
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, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
Eligibility Criteria
You may qualify if:
- Functional MR 2+ - 4+ with left ventricular enlargement
- Symptomatic heart failure
- % - 50% LVEF
You may not qualify if:
- mitral regurgitation of organic origins
- recent cardiac interventions
- severe comorbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Viacorlead
Study Sites (1)
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Related Publications (1)
Dubreuil O, Basmadjian A, Ducharme A, Thibault B, Crepeau J, Lam JY, Bilodeau L. Percutaneous mitral valve annuloplasty for ischemic mitral regurgitation: first in man experience with a temporary implant. Catheter Cardiovasc Interv. 2007 Jun 1;69(7):1053-61. doi: 10.1002/ccd.21186.
PMID: 17525965BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Luc Bilodeau, MD
Montreal Heart Institute
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 12, 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