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

NCT ID: NCT00572091

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/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-11-30

Brief Summary

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Improvement in 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 Implant

Intervention Type DEVICE

Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.

Interventions

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PTMA Implant

Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic heart failure
* functional MR 2+ - 4+
* LVEF 20% - 50%

Exclusion Criteria

* MR of organic origins
* significant co-morbidities
Minimum Eligible Age

50 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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Rainer Hoffmann, MD

Role: PRINCIPAL_INVESTIGATOR

Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Locations

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Rheinisch-Westfalische Technische Hochschule, Universitätsklinikum Aachen

Aachen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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06-055P

Identifier Type: -

Identifier Source: org_study_id