Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKlinik für Kardiologie, Pneumologie und Angiologie

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Assessment of diameters of the aortic annulus using the different imaging modalities

Time frame
baseline
2

Implantation depth (ID) measured from NCC in fluoroscopic view

Time frame
baseline

Secondary outcomes

1

left ventricular contrast injection

Time frame
baseline
2

Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT).

Time frame
baseline
3

mean pressure gradient

Time frame
baseline
4

paravalvular aortic regurgitation

Time frame
baseline

Other outcomes

1

Major Adverse Cardiac Event

Time frame
1 month, 3 months and 12 months
2

Hospitalisation

Time frame
1 month, 3 months and 12 months
3

Mortality

Time frame
1 month, 3 months and 12 months
4

blood samples

Time frame
1 month, 3 months and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Klinik für Kardiologie, Pneumologie und Angiologie

Lead sponsor

Heinrich-Heine University, Duesseldorf

Sponsor institution