Brief Title
Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI
Official Title
Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
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
Study Type
Interventional
Primary Outcome
Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
Condition
Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography
Intervention
Echography GE Healthcare Vivid E9
Study Arms / Comparison Groups
TAVI
Description: Echocardiography after TAVI
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
200
Start Date
May 2013
Completion Date
October 2014
Primary Completion Date
October 2014
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01966146
Organization ID
12-067
Responsible Party
Sponsor
Study Sponsor
RWTH Aachen University
Study Sponsor
, ,
Verification Date
December 2014