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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Echography GE Healthcare Vivid E9
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitätsklinikum RWTH Aachen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TAVI

MitraClip

Arm Description

Echocardiography after TAVI

Echocardiography after MitraClip procedure

Outcomes

Primary Outcome Measures

Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures

Secondary Outcome Measures

Full Information

First Posted
July 17, 2013
Last Updated
December 1, 2014
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01966146
Brief Title
Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI
Acronym
3D_TTE_TAVI
Official Title
Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Echocardiography: GE Healthcare Vivid E9

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis, Mitral Valve Insufficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAVI
Arm Type
Experimental
Arm Description
Echocardiography after TAVI
Arm Title
MitraClip
Arm Type
Experimental
Arm Description
Echocardiography after MitraClip procedure
Intervention Type
Device
Intervention Name(s)
Echography GE Healthcare Vivid E9
Intervention Description
Echography GE Healthcare Vivid E9
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Universitätsklinikum RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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

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