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

R

RWTH Aachen University

Status

Completed

Conditions

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

Treatments

Device: Echography GE Healthcare Vivid E9

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

Echocardiography: GE Healthcare Vivid E9

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 2 patient groups

TAVI
Experimental group
Description:
Echocardiography after TAVI
Treatment:
Device: Echography GE Healthcare Vivid E9
MitraClip
Experimental group
Description:
Echocardiography after MitraClip procedure
Treatment:
Device: Echography GE Healthcare Vivid E9

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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