Montreal Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device

NCT ID: NCT00571610

Last Updated: 2008-11-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-11-30

Brief Summary

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Reduction in mitral regurgitation due to safe placement of a PTMA device in the coronary sinus.

Detailed Description

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Conditions

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Heart Failure Mitral Regurgitation

Keywords

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Heart Failure Mitral Regurgitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Functional MR 2+ - 4+ with left ventricular enlargement
* Symptomatic heart failure
* 20% - 50% LVEF

Exclusion Criteria

* mitral regurgitation of organic origins
* recent cardiac interventions
* severe comorbidities
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Viacor

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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Canada

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.

Reference Type BACKGROUND
PMID: 17525965 (View on PubMed)

Other Identifiers

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05-020P

Identifier Type: -

Identifier Source: org_study_id