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

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.

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Key information

Conditions

Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

Echocardiography: GE Healthcare Vivid E9

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echography GE Healthcare Vivid E9

Device

Echography GE Healthcare Vivid E9

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Acronym: 3D_TTE_TAVI

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Oct 21, 2013
Registry last updated: Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed