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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01966146

Acronym

3D_TTE_TAVI

Enrollment

200

Registered

2013-10-21

Start date

2013-05-31

Completion date

2014-10-31

Last updated

2014-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

DEVICEEchography GE Healthcare Vivid E9

Echography GE Healthcare Vivid E9

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026