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Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

NCT ID: NCT00568230

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-11-30

Brief Summary

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Improvement of heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device.

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 with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.

Interventions

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PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* symptomatic heart failure
* moderate to severe mitral regurgitation
* 20 - 50% LVEF

Exclusion Criteria

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

50 Years

Maximum Eligible Age

80 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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Stefan Sack, MD

Role: PRINCIPAL_INVESTIGATOR

Universitat Duisburg-Essen

Locations

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Universitat Duisburg-Essen

Essen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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05-023P

Identifier Type: -

Identifier Source: org_study_id