About this trial
Transcatheter aortic valve implantation (TAVI) is an emerging alternative therapy for aortic stenosis for patients ineligible for open heart surgery or at high risk for perioperative complications. Pre-procedural imaging of the aortic root is essential for selection of the correct valve prosthesis and to minimize complications as prosthesis mismatch, possibly subsequent embolization, coronary obstruction, annulus rupture or severe aortic regurgitation.
The aim of the study is to compare the different imaging modalities for aortic root measurements.
Aortic root imaging will be performed prior to TAVI-procedure. The contrast injection will be performed either into the aorta or into the left ventricle. The datasets will be assessed by blinded-independent observers in a multi-planar reconstruction view.
The study will be performed retrospectively (2009-2012) and prospectively starting 2013.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aortic valve stenosis
screened for TAVI
written informed consent
Disqualifiers
unconsciousness, not able to consent
Trial population
patients with aortic valve stenosis screened for TAVI
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Assessment of diameters of the aortic annulus using the different imaging modalities
Implantation depth (ID) measured from NCC in fluoroscopic view
Secondary outcomes
left ventricular contrast injection
Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).
mean pressure gradient
paravalvular aortic regurgitation
Other outcomes
Major Adverse Cardiac Event
Hospitalisation
Mortality
blood samples
Sponsors and contacts
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Klinik für Kardiologie, Pneumologie und Angiologie
Lead sponsor
Heinrich-Heine University, Duesseldorf
Sponsor institution