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

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ClinicalTrials.gov Identifier: NCT01966146
Recruitment Status : Completed
First Posted : October 21, 2013
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography Aortic Stenosis Mitral Valve Insufficiency Device: Echography GE Healthcare Vivid E9 Not Applicable

Detailed Description:
Echocardiography: GE Healthcare Vivid E9

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
Study Start Date : May 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAVI
Echocardiography after TAVI
Device: Echography GE Healthcare Vivid E9
Echography GE Healthcare Vivid E9

Experimental: MitraClip
Echocardiography after MitraClip procedure
Device: Echography GE Healthcare Vivid E9
Echography GE Healthcare Vivid E9




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966146


Locations
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Germany
Universitätsklinikum RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01966146     History of Changes
Other Study ID Numbers: 12-067
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction