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

Aortic Stenosis Clinical Trial

— 3D_TTE_TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966146
• Other study ID #: 12-067
• Status: Completed
• Phase: N/A
• First received: July 17, 2013
• Last updated: December 1, 2014
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

Echocardiography: GE Healthcare Vivid E9

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

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

Intervention

Device:
• Echography GE Healthcare Vivid E9
Echography GE Healthcare Vivid E9

Locations

Country	Name	City	State
Germany	Universitätsklinikum RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No