Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation
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|ClinicalTrials.gov Identifier: NCT01805739|
Recruitment Status : Recruiting
First Posted : March 6, 2013
Last Update Posted : November 28, 2017
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.
|Condition or disease|
|Aortic Valve Stenosis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation (TAVI)|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
- Assessment of diameters of the aortic annulus using the different imaging modalities [ Time Frame: baseline ]
- left ventricular contrast injection [ Time Frame: baseline ]
- Comparison of pre-procedural TAVI-imaging for the assessment of the left ventricular outflow tract (LVOT). [ Time Frame: baseline ]
- Major Adverse Cardiac Event [ Time Frame: 1 month, 3 months and 12 months ]
- Hospitalisation [ Time Frame: 1 month, 3 months and 12 months ]
- Mortality [ Time Frame: 1 month, 3 months and 12 months ]
- blood samples [ Time Frame: 1 month, 3 months and 12 months ]
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): NCT01805739
|Contact: Malte Kelm, MD||0049 211 81 18800||CTSU@med.uni-duesseldorf.de|
|Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf||Recruiting|
|Duesseldorf, NRW, Germany, 40225|
|Contact: Malte Kelm, MD 0049 211 81 18800 CTSU@med.uni-duesseldorf.de|
|Principal Investigator: Malte Kelm, MD|
|Sub-Investigator: Florian Bönner, MD|
|Sub-Investigator: Katharina Hellhammer, MD|
|Sub-Investigator: Mirja Neizel-Wittke, MD|
|Sub-Investigator: Tobias Zeus, MD|
|Sub-Investigator: Ralf Westenfeld, MD|
|Sub-Investigator: Verena Veulemans, MD|
|Sub-Investigator: Laura Kleinebrecht, MD|
|Study Director:||Malte Kelm, MD||Division of Cardiology, Pulmonary Diseases, Vascular Medicine, University Hospital Duesseldorf|