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

Not Applicable

Completed

• Conditions: Mitral Valve Insufficiency; Aortic Stenosis; Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography
• Interventions: Device: Echography GE Healthcare Vivid E9

• Registration Number: NCT01966146
• Lead Sponsor: RWTH Aachen University

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 Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-07-17
• Study First Submitted QC: 2013-10-16
• Study First Posted: 2013-10-21
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVI	Echography GE Healthcare Vivid E9	Echocardiography after TAVI
MitraClip	Echography GE Healthcare Vivid E9	Echocardiography after MitraClip procedure

Primary Outcome Measures

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

Trial Locations

Locations (1)

Universitätsklinikum RWTH Aachen; 🇩🇪 Aachen, NRW, Germany