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Clinical Trials in Germany / NCT01805739
Recruiting Observational

Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation

NCT01805739 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2013-01
Last updated
2020-10-30

Condition(s) studied

Aortic Valve Stenosis

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * aortic valve stenosis * screened for TAVI * written informed consent Exclusion Criteria: * unconsciousness, not able to consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf Düsseldorf North Rhine-Westphalia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01805739 on ClinicalTrials.gov ↗ ← All trials in Germany