Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device
NCT ID: NCT00571610
Last Updated: 2008-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2006-04-30
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant.
PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Percutaneous access from right or left subclavian vein, diagnostic assessment, then placement of the PTMA implant in the coronary sinus, great cardiac vein.
Interventions
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PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
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
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Inclusion Criteria
* Symptomatic heart failure
* 20% - 50% LVEF
Exclusion Criteria
* recent cardiac interventions
* severe comorbidities
40 Years
75 Years
ALL
No
Sponsors
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Viacor
INDUSTRY
Responsible Party
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Viacor, Inc.
Principal Investigators
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Luc Bilodeau, MD
Role: PRINCIPAL_INVESTIGATOR
Montreal Heart Institute
Locations
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Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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05-020P
Identifier Type: -
Identifier Source: org_study_id