NCT01966146CompletedNot Applicable
Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RWTH Aachen University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Ventripoint Single Ventricle StudySingle-ventricleCongenital Heart DiseaseNCT05262907Duke University100
Completed
Phase 4
QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit LesionsCoronary Artery DiseaseNCT04808310Johannes Gutenberg University Mainz200
Completed
Not Applicable
Establishment and Application of 3-Dimensional (3-D) Cell Culture Model of Clinical Circulating Tumor Cells (CTCs)Cell CarcinomaNCT05623748Chang Gung Memorial Hospital160
Completed
Unknown
Establishment of cardiac function evaluation method for congenital heart disease using high-speed Cine MRI imagingCongenital Heart DiseaseJPRN-jRCT1090220389Makoto Orii50
Completed
Not Applicable
Assessment of S-ICD Eligibility With 12-Lead ECGImplantable Defibrillator UserNCT03209726Larisa Tereshchenko106