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Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI

NCT ID: NCT01966146

Last Updated: 2014-12-02

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

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.

Detailed Description

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Echocardiography: GE Healthcare Vivid E9

Conditions

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Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography Aortic Stenosis Mitral Valve Insufficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TAVI

Echocardiography after TAVI

Group Type EXPERIMENTAL

Echography GE Healthcare Vivid E9

Intervention Type DEVICE

Echography GE Healthcare Vivid E9

MitraClip

Echocardiography after MitraClip procedure

Group Type EXPERIMENTAL

Echography GE Healthcare Vivid E9

Intervention Type DEVICE

Echography GE Healthcare Vivid E9

Interventions

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Echography GE Healthcare Vivid E9

Echography GE Healthcare Vivid E9

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve
* patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System
* Patients who are aged above 18 years and legally competent
* signed informed consent

Exclusion Criteria

* patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities \> stage 1
* patients with atrial fibrillation
* pregnant and breast-feeding women
* patients with disturbed central nerve system
* patients with pacemaker, implants, ferrous clamps,insulin pump
* patients with tattoo
* patients with claustrophobia
* patiens with asthma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universitätsklinikum RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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12-067

Identifier Type: -

Identifier Source: org_study_id