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

December 1, 2014 updated by: RWTH Aachen University

Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Echocardiography: GE Healthcare Vivid E9

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • Universitätsklinikum RWTH Aachen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAVI
Echocardiography after TAVI
Device: Echography GE Healthcare Vivid E9
Echography GE Healthcare Vivid E9
Experimental: MitraClip
Echocardiography after MitraClip procedure
Device: Echography GE Healthcare Vivid E9
Echography GE Healthcare Vivid E9

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
Time Frame: Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month
Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 17, 2013

First Submitted That Met QC Criteria

October 16, 2013

First Posted (Estimate)

October 21, 2013

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-067

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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